Medical device manufacturer
Medtronic Sofamor Danek, Inc.
Medtronic Sofamor Danek, Inc. holds 253 FDA 510(k) clearances across 28 product codes. Median elapsed review time is 61 days. openFDA lists no recall records naming the company. FDA publishes it under 2 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 253
- Product codes
- 28
- Median review
- 61 days
- Recall records
- 0
How does FDA spell Medtronic Sofamor Danek, Inc.?
FDA publishes this company under 2 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 |
|---|---|---|
| Medtronic Sofamor Danek | device/510k | normalised |
| Medtronic Sofamor Danek, Inc. | 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 Medtronic Sofamor Danek, Inc. file in?
28 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 50 | 50 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 44 | 34 days | |
| MQP | Spinal Vertebral Body Replacement Device | 30 | 30 days | |
| MNI | Orthosis, Spinal Pedicle Fixation | 23 | 28 days | |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 20 | 30 days | |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 18 | 86 days | |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 17 | 51 days | |
| MQV | Filler, Bone Void, Calcium Compound | 11 | 130 days | |
| JDK | Prosthesis, Hip, Cement Restrictor | 5 | 29 days | |
| HRX | Arthroscope | 3 | 65 days | |
| MRW | System, Facet Screw Spinal Device | 3 | 30 days | |
| NUN | Bone Grafting Material, Human Source | 3 | 75 days | |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 | 152 days | |
| LYC | Bone Grafting Material, Synthetic | 2 | 85 days | |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 2 | 201 days | |
| NDN | Cement, Bone, Vertebroplasty | 2 | 70 days | |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 2 | 131 days | |
| NVR | Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar | 2 | 112 days | |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 57 days | |
| OUR | Sacroiliac Joint Fixation | 2 | 106 days | |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 75 days | |
| GAD | Retractor | 1 | 56 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 85 days | |
| HBB | Motor, Drill, Pneumatic | 1 | 120 days | |
| JDR | Staple, Fixation, Bone | 1 | 90 days |
Showing the 25 they file in most, of 28.
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 Medtronic Sofamor Danek, 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 Medtronic Sofamor Danek, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K251193 | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft | MQV | 56 | |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | MQV | 49 | |
| K230716 | Robotic Graft Delivery Instruments | OLO | 125 | |
| K212428 | Centerpiece Plate Fixation System | NQW | 131 | |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | MAX | 106 | |
| K173125 | T2 STRATOSPHERE Expandable Corpectomy System | MQP | 82 | |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium | MAX | 60 | |
| K171031 | CRESCENT Spinal System | MAX | 91 | |
| K171468 | FUSE Spinal System | MAX | 26 | |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems | NKB | 66 |
Source: openFDA device/510k · retrieved
Watch what Medtronic Sofamor Danek, 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.