The following data is part of a premarket notification filed by Synthes (usa) Llc with the FDA for Trumatch Graft Cage - Long Bone.
| Device ID | K180821 |
| 510k Number | K180821 |
| Device Name: | TruMatch Graft Cage - Long Bone |
| Classification | Plate, Fixation, Bone |
| Applicant | Synthes (USA) LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Christopher J. Medberry |
| Correspondent | Christopher J. Medberry Synthes (USA) LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2018-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886982262479 | K180821 | 000 |
| 10886982262462 | K180821 | 000 |