Medical device manufacturer
K2M, Inc.
K2M, Inc. holds 127 FDA 510(k) clearances across 18 product codes. Median elapsed review time is 89 days. openFDA lists 39 recall records naming the company. FDA publishes it under 9 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 127
- Product codes
- 18
- Median review
- 89 days
- Recall records
- 39
How does FDA spell K2M, Inc.?
FDA publishes this company under 9 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| K2M, INC. | device/registrationlisting | normalised |
| K2M, Inc | device/enforcement | normalised |
| K2M, Inc | device/recall | normalised |
| K2M, Inc. | device/recall | normalised |
| K2M, Inc. | device/enforcement | normalised |
| K2m | device/510k | normalised |
| K2m, Inc. | device/510k | normalised |
| K2m, Incorporated | device/510k | normalised |
Showing 8 of 9.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does K2M, Inc. file in?
18 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 20 | 82 days | |
| NKB | Thoracolumbosacral Pedicle Screw System | 20 | 60 days | |
| MNI | Orthosis, Spinal Pedicle Fixation | 15 | 80 days | |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 13 | 90 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 12 | 80 days | |
| MQP | Spinal Vertebral Body Replacement Device | 8 | 97 days | |
| OLO | Orthopedic Stereotaxic Instrument | 7 | 118 days | |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 7 | 208 days | |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 6 | 80 days | |
| NKG | Posterior Cervical Screw System | 5 | 87 days | |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 84 days | |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 93 days | |
| OWI | Bone Fixation Cerclage, Sublaminar | 3 | 93 days | |
| JDQ | Cerclage, Fixation | 1 | 144 days | |
| KNW | Instrument, Biopsy | 1 | 97 days | |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 92 days | |
| PGM | Growing Rod System | 1 | 101 days | |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 1 | 300 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has K2M, Inc. had a recall?
openFDA lists 39 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1307-2022Class IIOpen, ClassifiedKWP
Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue.
Z-0705-2022Class IIOpen, ClassifiedKWP
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
Z-0706-2022Class IIOpen, ClassifiedKWP
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
Z-0104-2022Class IITerminatedOVE
Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
Z-1695-2021Class IITerminatedMAX
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Showing the 5 most recently initiated of 39.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has K2M, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K260546 | Q Pedicle Instruments | OLO | 27 | |
| K253545 | Vulcan Spinal System | NKB | 88 | |
| K252873 | Q Interbody Instruments | OLO | 149 | |
| K211320 | CAPRI Corpectomy Cage System | PLR | 300 | |
| K202528 | Cannulated Power Driver Attachment | NKB | 55 | |
| K201006 | K2M Navigation Instruments | OLO | 112 | |
| K193203 | MOJAVE Expandable Interbody System | MAX | 90 | |
| K193129 | Yukon OCT Spinal System | NKG | 87 | |
| K192911 | Brainlab Compatible K2M Navigation Instruments | OLO | 30 | |
| K190179 | SAHARA Stabilization System | OVD | 244 |
Source: openFDA device/510k · retrieved
Where is K2M, Inc. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what K2M, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.