The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Titan Rc Tack.
| Device ID | K994269 |
| 510k Number | K994269 |
| Device Name: | TITAN RC TACK |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
| Contact | Kathleen Morahan |
| Correspondent | Kathleen Morahan INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-20 |
| Decision Date | 2000-01-10 |
| Summary: | summary |