The following data is part of a premarket notification filed by Neoligaments, Ltd. with the FDA for Fastlok (staple And Buckle) Fixation System.
| Device ID | K904340 |
| 510k Number | K904340 |
| Device Name: | FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM |
| Classification | Staple, Fixation, Bone |
| Applicant | NEOLIGAMENTS, LTD. 99 WALNUT ST. SUITE B Saugus, MA 01906 |
| Contact | Kenneth E Carrier |
| Correspondent | Kenneth E Carrier NEOLIGAMENTS, LTD. 99 WALNUT ST. SUITE B Saugus, MA 01906 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-20 |
| Decision Date | 1990-10-19 |