The following data is part of a premarket notification filed by Straumann Usa, Inc. with the FDA for Bone Block Fixation Set.
| Device ID | K050515 |
| 510k Number | K050515 |
| Device Name: | BONE BLOCK FIXATION SET |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | STRAUMANN USA, INC. 1601 TRAPELO RD. Waltham, MA 02451 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert STRAUMANN USA, INC. 1601 TRAPELO RD. Waltham, MA 02451 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-01 |
| Decision Date | 2005-04-05 |
| Summary: | summary |