The following data is part of a premarket notification filed by Neoligaments, Ltd. with the FDA for Graftologer Pgh & Acl Reconstruction Instrument Set.
| Device ID | K952543 |
| 510k Number | K952543 |
| Device Name: | GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | NEOLIGAMENTS, LTD. 28-30 BLENHEIM TERRACE Leeds, GB Ls2-9hd |
| Contact | Jrj Rowland |
| Correspondent | Jrj Rowland NEOLIGAMENTS, LTD. 28-30 BLENHEIM TERRACE Leeds, GB Ls2-9hd |
| Product Code | HWE |
| Subsequent Product Code | FZX |
| Subsequent Product Code | HWA |
| Subsequent Product Code | HWB |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-18 |
| Decision Date | 1995-06-22 |