Cranial Surgical Planning And Instrument Guides
Regulation 882.4310
1510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PPT
| Company | 510(k)s | Recalls |
|---|---|---|
| KLS-Martin L.P. | 2 | 0 |
| 3D Systems, Inc. | 1 | 0 |
| Materialise NV | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 7, 2026 | K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models Materialise NV, BE | PPT |
| Aug 31, 2020 | K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. | PPT |
| Jul 26, 2019 | K182889 | KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. | PPT |
| Sep 23, 2016 | K151285 | VSP Cranial System 3D Systems, Inc. | PPT |
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