The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Retrograde Pediatric Nail.
| Device ID | K980854 |
| 510k Number | K980854 |
| Device Name: | RETROGRADE PEDIATRIC NAIL |
| Classification | Pin, Fixation, Smooth |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Debbie De Los Santos |
| Correspondent | Debbie De Los Santos ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-05 |
| Decision Date | 1998-08-11 |
| Summary: | summary |