The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Ezstart Interference Screw.
| Device ID | K182955 |
| 510k Number | K182955 |
| Device Name: | EZStart Interference Screw |
| Classification | Screw, Fixation, Bone |
| Applicant | ConMed Corporation 525 French Road Utica, NY 13502 |
| Contact | Jeremy Walter |
| Correspondent | Jeremy Walter ConMed Corporation 525 French Road Utica, NY 13502 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-24 |
| Decision Date | 2019-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854901134 | K182955 | 000 |
| 20845854050603 | K182955 | 000 |
| 20845854001124 | K182955 | 000 |
| 20845854001056 | K182955 | 000 |
| 20845854001049 | K182955 | 000 |
| 20845854001032 | K182955 | 000 |
| 20845854001018 | K182955 | 000 |
| 20845854600044 | K182955 | 000 |
| 20845854050665 | K182955 | 000 |
| 20845854050658 | K182955 | 000 |
| 20845854050627 | K182955 | 000 |
| 20845854050610 | K182955 | 000 |
| 20845854001155 | K182955 | 000 |
| 20845854050634 | K182955 | 000 |
| 20845854050641 | K182955 | 000 |
| 20845854600020 | K182955 | 000 |
| 20845854901127 | K182955 | 000 |
| 20845854901110 | K182955 | 000 |
| 20845854901097 | K182955 | 000 |
| 20845854901080 | K182955 | 000 |
| 20845854901073 | K182955 | 000 |
| 20845854901059 | K182955 | 000 |
| 20845854901042 | K182955 | 000 |
| 20845854901035 | K182955 | 000 |
| 20845854901011 | K182955 | 000 |
| 20845854850609 | K182955 | 000 |
| 20845854600051 | K182955 | 000 |
| 20845854600037 | K182955 | 000 |
| 20845854001148 | K182955 | 000 |