The following data is part of a premarket notification filed by Neoligaments, Ltd. with the FDA for Fastlok (staple & Buckle) Fixation System.
| Device ID | K913461 |
| 510k Number | K913461 |
| Device Name: | FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM |
| Classification | Staple, Fixation, Bone |
| Applicant | NEOLIGAMENTS, LTD. 380 LOWELL STREET, SUITE 202A Wakefield, MA 01880 |
| Contact | Kenneth E Carrier |
| Correspondent | Kenneth E Carrier NEOLIGAMENTS, LTD. 380 LOWELL STREET, SUITE 202A Wakefield, MA 01880 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-05 |
| Decision Date | 1991-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060267130112 | K913461 | 000 |
| 05060267130099 | K913461 | 000 |
| 05060267133304 | K913461 | 000 |
| 05060267133298 | K913461 | 000 |