The following data is part of a premarket notification filed by Neoligaments, Ltd. with the FDA for Cradle Fixation Device.
| Device ID | K941772 |
| 510k Number | K941772 |
| Device Name: | CRADLE FIXATION DEVICE |
| Classification | Staple, Fixation, Bone |
| Applicant | NEOLIGAMENTS, LTD. 28-30 BLENHEIM TERRACE Leeds, GB Ls2-9hd |
| Contact | J.r.j. Rowland |
| Correspondent | J.r.j. Rowland NEOLIGAMENTS, LTD. 28-30 BLENHEIM TERRACE Leeds, GB Ls2-9hd |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-11 |
| Decision Date | 1995-08-07 |