The following data is part of a premarket notification filed by Normed Medizin-technik Gmbh with the FDA for Tenodesis Screw System.
| Device ID | K151701 |
| 510k Number | K151701 |
| Device Name: | Tenodesis Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | NORMED MEDIZIN-TECHNIK GMBH ULRICHSTRASSE 7 Tuttlingen, DE D-78532 |
| Contact | Arne Briest |
| Correspondent | Arne Briest NORMED MEDIZIN-TECHNIK GMBH ULRICHSTRASSE 7 Tuttlingen, DE D-78532 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-24 |
| Decision Date | 2016-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024110380 | K151701 | 000 |
| 00889024110373 | K151701 | 000 |
| 00889024110366 | K151701 | 000 |
| 00889024110359 | K151701 | 000 |
| 00889024110342 | K151701 | 000 |
| 00889024110335 | K151701 | 000 |