The following data is part of a premarket notification filed by Conmed Corporation, Largo with the FDA for C-wire Double Ended Orthopedic Wires.
| Device ID | K142134 |
| 510k Number | K142134 |
| Device Name: | C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES |
| Classification | Pin, Fixation, Smooth |
| Applicant | CONMED CORPORATION, LARGO 11311 CONCEPT BLVD Largo, FL 33773 |
| Contact | Joy Lovett |
| Correspondent | Joy Lovett CONMED CORPORATION, LARGO 11311 CONCEPT BLVD Largo, FL 33773 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-04 |
| Decision Date | 2014-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854033330 | K142134 | 000 |
| 20845854029081 | K142134 | 000 |
| 20845854029098 | K142134 | 000 |
| 20845854029104 | K142134 | 000 |
| 20845854029111 | K142134 | 000 |
| 20845854029128 | K142134 | 000 |
| 20845854029135 | K142134 | 000 |
| 20845854029142 | K142134 | 000 |
| 20845854029159 | K142134 | 000 |
| 20845854029166 | K142134 | 000 |
| 20845854029173 | K142134 | 000 |
| 20845854033286 | K142134 | 000 |
| 20845854033293 | K142134 | 000 |
| 20845854033309 | K142134 | 000 |
| 20845854033316 | K142134 | 000 |
| 20845854033323 | K142134 | 000 |