The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Acromed Ads Bone Nail Driver.
| Device ID | K875054 |
| 510k Number | K875054 |
| Device Name: | ACROMED ADS BONE NAIL DRIVER |
| Classification | Driver, Prosthesis |
| Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | HWR |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-09 |
| Decision Date | 1988-01-28 |