The following data is part of a premarket notification filed by Orthotech with the FDA for Orthotec K-cap System.
| Device ID | K971453 |
| 510k Number | K971453 |
| Device Name: | ORTHOTEC K-CAP SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | ORTHOTECH 1053 KOLOA ST. Honolulu, HI 96816 |
| Contact | Patrick Bertranou |
| Correspondent | Patrick Bertranou ORTHOTECH 1053 KOLOA ST. Honolulu, HI 96816 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-21 |
| Decision Date | 1997-06-24 |
| Summary: | summary |