The following data is part of a premarket notification filed by Tyber Medical Llc with the FDA for Tyber Medical Wedge System.
| Device ID | K171327 |
| 510k Number | K171327 |
| Device Name: | Tyber Medical Wedge System |
| Classification | Bone Wedge |
| Applicant | Tyber Medical LLC 83 S Commerce Way, Suite 310 Bethlehem, PA 18017 |
| Contact | Mark F. Schenk |
| Correspondent | Mark F. Schenk Tyber Medical LLC 83 S Commerce Way, Suite 310 Bethlehem, PA 18017 |
| Product Code | PLF |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-05 |
| Decision Date | 2017-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M69535000001210 | K171327 | 000 |