The following data is part of a premarket notification filed by Stuart Drug & Surgical Supply, Inc. with the FDA for Stuart Cannulated Cancellous Bone Fixation Screw.
| Device ID | K881327 |
| 510k Number | K881327 |
| Device Name: | STUART CANNULATED CANCELLOUS BONE FIXATION SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | STUART DRUG & SURGICAL SUPPLY, INC. ONE STUART PLAZA DONOHUE/LUXOR ROADS Greensburg, PA 15601 |
| Contact | Abraham Glasser |
| Correspondent | Abraham Glasser STUART DRUG & SURGICAL SUPPLY, INC. ONE STUART PLAZA DONOHUE/LUXOR ROADS Greensburg, PA 15601 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-30 |
| Decision Date | 1988-05-25 |