The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Absorbable Bone Screw.
| Device ID | K944544 |
| 510k Number | K944544 |
| Device Name: | ABSORBABLE BONE SCREW |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 20 LAKE DR. CN 7060 East Windsor, NJ 08520 |
| Contact | Amy Waters |
| Correspondent | Amy Waters JOHNSON & JOHNSON PROFESSIONALS, INC. 20 LAKE DR. CN 7060 East Windsor, NJ 08520 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-15 |
| Decision Date | 1996-01-26 |