The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Transtend Br Anchor W/ Orthocord, Transtend Ti Anchor W/orthocord, Transtend Peek Anchor W/orthocord, Healix Transtend.
| Device ID | K102298 |
| 510k Number | K102298 |
| Device Name: | TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND |
| Classification | Screw, Fixation, Bone |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Kristine Christo |
| Correspondent | Kristine Christo DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | HWC |
| Subsequent Product Code | MAI |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-13 |
| Decision Date | 2011-01-07 |
| Summary: | summary |