The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Interlocking Femoral Nail(left & Right) Tibial Nai.
| Device ID | K852020 |
| 510k Number | K852020 |
| Device Name: | INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw, IN 46580 |
| Contact | James Ritter |
| Correspondent | James Ritter WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw, IN 46580 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-08 |
| Decision Date | 1985-05-22 |