Cover, Burr Hole
Regulation 882.5250
1510(k)s in 12 months (29 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in GXR
| Company | 510(k)s | Recalls |
|---|---|---|
| Neos Surgery S.L | 4 | 0 |
| Synthes (Usa) | 4 | 0 |
| Aesculap, Inc. | 2 | 0 |
| NeuroPace, Inc. | 2 | 0 |
| Ossdsign AB | 2 | 0 |
| St Jude Medical | 2 | 0 |
| Biomet Microfixation | 1 | 0 |
| Chendu Medart Medical Scientific Co., Ltd. | 1 | 0 |
| Holter-Hausner Intl. | 1 | 0 |
| Image-Guided Neurologics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2021 | Medtronic Neuromodulation Medtronic StimLoc Burr Hole Cover, Part Numbers:
a) 3387S-40
b) 3389S-28
c) 3389S-40
d) 3391S-40
e) 3550S-01
f) 924256
g) DB-5000 Open, Classified |
GXR | K001096 |
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