The following data is part of a premarket notification filed by Synthes Usa Products, Llc with the FDA for Depuy Synthes 2.0 Mm Quick Insertion Screws.
| Device ID | K180541 |
| 510k Number | K180541 |
| Device Name: | DePuy Synthes 2.0 Mm Quick Insertion Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | Synthes USA Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Nicholas Fountoulakis |
| Correspondent | Rebecca G. Reiter Synthes USA Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-01 |
| Decision Date | 2018-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612334119063 | K180541 | 000 |
| 10886982263179 | K180541 | 000 |
| 10886982263186 | K180541 | 000 |
| 10886982263193 | K180541 | 000 |
| 10886982263209 | K180541 | 000 |
| 10886982263216 | K180541 | 000 |
| 10886982263223 | K180541 | 000 |
| 10886982263230 | K180541 | 000 |
| 07612334119056 | K180541 | 000 |
| 10886982263360 | K180541 | 000 |
| 10886982263377 | K180541 | 000 |
| 10886982263384 | K180541 | 000 |
| 10886982263391 | K180541 | 000 |
| 10886982263407 | K180541 | 000 |
| 10886982263414 | K180541 | 000 |
| 10886982263421 | K180541 | 000 |
| 10886982263438 | K180541 | 000 |
| 10886982263162 | K180541 | 000 |