The following data is part of a premarket notification filed by Linvatec Biomaterials, Ltd. with the FDA for Duet Suture Anchor, Models Bxs4216, Bxs4216h; Impact Suture Anchor, Models Bxs4218, Bxs4218h.
| Device ID | K042966 |
| 510k Number | K042966 |
| Device Name: | DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | LINVATEC BIOMATERIALS, LTD. HERMIANKATU 6-8L Tampere, FI |
| Contact | Tuija Annala |
| Correspondent | Tuija Annala LINVATEC BIOMATERIALS, LTD. HERMIANKATU 6-8L Tampere, FI |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-28 |
| Decision Date | 2004-11-19 |
| Summary: | summary |