The following data is part of a premarket notification filed by George Tiemann & Co. with the FDA for Titaniuim Bone Screw.
| Device ID | K853869 |
| 510k Number | K853869 |
| Device Name: | TITANIUIM BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | GEORGE TIEMANN & CO. 84 NEWTOWN PLAZA Plainview, NY 11803 |
| Contact | Richard Moriarty |
| Correspondent | Richard Moriarty GEORGE TIEMANN & CO. 84 NEWTOWN PLAZA Plainview, NY 11803 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-17 |
| Decision Date | 1985-12-09 |