The following data is part of a premarket notification filed by O.m.t. Oberflachen-und Materialtechnologie Gmbh with the FDA for Oss/(scarf)- And Osw-screw.
| Device ID | K042079 |
| 510k Number | K042079 |
| Device Name: | OSS/(SCARF)- AND OSW-SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | O.M.T. OBERFLACHEN-UND MATERIALTECHNOLOGIE GMBH 1327 7TH AVENUE Huntington, WV 25701 |
| Contact | H. Darrel Darby Ii |
| Correspondent | H. Darrel Darby Ii O.M.T. OBERFLACHEN-UND MATERIALTECHNOLOGIE GMBH 1327 7TH AVENUE Huntington, WV 25701 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-02 |
| Decision Date | 2004-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420135926 | K042079 | 000 |
| 00840420135803 | K042079 | 000 |
| 00840420135834 | K042079 | 000 |
| 00840420135841 | K042079 | 000 |
| 00840420135858 | K042079 | 000 |
| 00840420135865 | K042079 | 000 |
| 00840420135872 | K042079 | 000 |
| 00840420135889 | K042079 | 000 |
| 00840420135896 | K042079 | 000 |
| 00840420135902 | K042079 | 000 |
| 00840420135919 | K042079 | 000 |
| 00840420135742 | K042079 | 000 |