Panels › Orthopedic › Product code MNH · Class 2
Orthosis, Spondylolisthesis Spinal Fixation
Regulation 888.3070
0510(k)s in 12 months (309 all time)
0recalls in 12 months (15 all time)
14recalls that name a 510(k)
Top companies in MNH
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 18 | 0 |
| Acromed Corp. | 14 | 0 |
| Depuyacromed | 13 | 0 |
| Sofamor Danek | 10 | 0 |
| Ebi, L.P. | 6 | 3 |
| Howmedica Osteonics | 9 | 0 |
| Advanced Spine Fixation Systems, Inc. | 8 | 0 |
| Stryker Spine | 4 | 3 |
| Ortho Tec, LLC | 6 | 0 |
| Solco Biomedical Co., Ltd. | 6 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 1995 | K944737 | ISOLA SPINE SYSTEM Acromed Corp. | MNH |
| Jun 20, 1995 | K930353 | SIMMONS PLATING SYSTEM BOLT AND SCREW Smith & Nephew, Inc. | MNH |
| Jun 14, 1995 | K930298 | ROGOZINSKI SPINAL ROD SYSTEM SCREW Smith & Nephew Richards, Inc. | MNH |
| May 30, 1995 | K944756 | ISOLA OPEN AND CLOSED SCREWS Acromed Corp. | MNH |
| May 5, 1995 | K944736 | VSP (VARIABLE SCREW PLACEMENT) Acromed Corp. | MNH |
| Apr 26, 1995 | K945064 | SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. | MNH |
| Apr 26, 1995 | K943775 | SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. | MNH |
| Feb 14, 1995 | K942387 | SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. | MNH |
| Jan 20, 1995 | K932029 | TSRH SPINAL SCREWS Sofamor Danek Mfg., Inc. | MNH |
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