The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Depuy Synthes 2.4mm Lcp Straight Wrist Plate, Sterile.
| Device ID | K192327 |
| 510k Number | K192327 |
| Device Name: | DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile |
| Classification | Plate, Fixation, Bone |
| Applicant | Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Thomas Shea |
| Correspondent | Thomas Shea Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-27 |
| Decision Date | 2019-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886982291226 | K192327 | 000 |