The following data is part of a premarket notification filed by Brasseler Usa I, L.p. with the FDA for 2.0 X 6mm Screw.
| Device ID | K955140 |
| 510k Number | K955140 |
| Device Name: | 2.0 X 6MM SCREW |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | BRASSELER USA I, L.P. 800 KING GEORGE BLVD. Savannah, GA 31405 |
| Contact | Courtney S Paradice |
| Correspondent | Courtney S Paradice BRASSELER USA I, L.P. 800 KING GEORGE BLVD. Savannah, GA 31405 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-01-05 |