The following data is part of a premarket notification filed by Core Essence Orthopaedics, Inc. with the FDA for Tac-tite (tm).
| Device ID | K090128 |
| 510k Number | K090128 |
| Device Name: | TAC-TITE (TM) |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | CORE ESSENCE ORTHOPAEDICS, INC. 301 OXFORD VALLEY RD. SUITE 905B Yardley, PA 19067 |
| Contact | Shawn T Huxel |
| Correspondent | Shawn T Huxel CORE ESSENCE ORTHOPAEDICS, INC. 301 OXFORD VALLEY RD. SUITE 905B Yardley, PA 19067 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-03-19 |
| Summary: | summary |