The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Steadman Ligament Graft Passer And Protector.
| Device ID | K941896 |
| 510k Number | K941896 |
| Device Name: | STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | David A Kotkovetz |
| Correspondent | David A Kotkovetz DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-18 |
| Decision Date | 1994-11-07 |