The following data is part of a premarket notification filed by Aap International, Ltd. with the FDA for Aap Bone Screw.
| Device ID | K915316 |
| 510k Number | K915316 |
| Device Name: | AAP BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | AAP INTERNATIONAL, LTD. 420 ROUTE 206 NORTH, SUITE 200 Bedminster, NJ 07921 |
| Contact | Wayne R Knupp |
| Correspondent | Wayne R Knupp AAP INTERNATIONAL, LTD. 420 ROUTE 206 NORTH, SUITE 200 Bedminster, NJ 07921 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-22 |
| Decision Date | 1992-02-14 |