The following data is part of a premarket notification filed by Union Surgical Llc with the FDA for T-pin.
| Device ID | K053513 |
| 510k Number | K053513 |
| Device Name: | T-PIN |
| Classification | Pin, Fixation, Threaded |
| Applicant | UNION SURGICAL LLC 834 CHESTNUT STREET SUITE G114 Philadelphia, PA 19107 |
| Contact | Al Weisenborn |
| Correspondent | Al Weisenborn UNION SURGICAL LLC 834 CHESTNUT STREET SUITE G114 Philadelphia, PA 19107 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-16 |
| Decision Date | 2006-01-13 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() T-PIN 78743672 3299489 Live/Registered |
Union Surgical, LLC 2005-10-31 |
![]() T-PIN 73298683 not registered Dead/Abandoned |
TP LABORATORIES, INC. 0000-00-00 |