Patient Specific Manual Orthopedic Stereotaxic System
Regulation 882.4560
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OSF
| Company | 510(k)s | Recalls |
|---|---|---|
| Surgical Planning Associates | 3 | 0 |
| Materialise N.V. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2015 | Materialise N.V. Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient C Terminated |
OSF | K102795 |
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