Medical device manufacturer
Life Spine, Inc.
Life Spine, Inc. holds 122 FDA 510(k) clearances across 21 product codes. Median elapsed review time is 91 days. openFDA lists no recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 122
- Product codes
- 21
- Median review
- 91 days
- Recall records
- 0
How does FDA spell Life Spine, Inc.?
FDA publishes this company under 4 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 |
|---|---|---|
| LIFE SPINE | device/registrationlisting | normalised |
| Life Spine | device/510k | normalised |
| Life Spine, Inc. | device/510k | normalised |
| Life Spine, LLC | device/510k | normalised |
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 Life Spine, Inc. file in?
21 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 32 | 82 days | |
| NKB | Thoracolumbosacral Pedicle Screw System | 22 | 74 days | |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 14 | 71 days | |
| MNI | Orthosis, Spinal Pedicle Fixation | 7 | 64 days | |
| HWC | Screw, Fixation, Bone | 6 | 111 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 5 | 182 days | |
| OUR | Sacroiliac Joint Fixation | 5 | 93 days | |
| HRS | Plate, Fixation, Bone | 4 | 73 days | |
| NKG | Posterior Cervical Screw System | 4 | 62 days | |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 160 days | |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 | 129 days | |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 245 days | |
| JDK | Prosthesis, Hip, Cement Restrictor | 2 | 26 days | |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 2 | 63 days | |
| OLO | Orthopedic Stereotaxic Instrument | 2 | 103 days | |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 260 days | |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 1 | 271 days | |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 112 days | |
| MRW | System, Facet Screw Spinal Device | 1 | 88 days | |
| NVR | Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar | 1 | 117 days | |
| PEK | Spinous Process Plate | 1 | 263 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 Life Spine, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
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 Life Spine, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | OLO | 103 | |
| K260837 | VersaLift Expandable System | MAX | 60 | |
| K254274 | ARx® SAI Implant System | NKB | 107 | |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | MAX | 59 | |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | MAX | 53 | |
| K250373 | ProLift Expandable Spacer System | MAX | 58 | |
| K243668 | ProLift Pivot Expandable Spacer System | MAX | 57 | |
| K243369 | Cervical Plating System | KWQ | 42 | |
| K242826 | ProLift Wedge Expandable Spacer System | MAX | 20 | |
| K241464 | ARx® SAI Implant System | OUR | 67 |
Source: openFDA device/510k · retrieved
Where is Life Spine, 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 Life Spine, Inc. files next
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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.