The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Matrixwave Mmf System.
| Device ID | K141165 |
| 510k Number | K141165 |
| Device Name: | MATRIXWAVE MMF SYSTEM |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Damon Lees |
| Correspondent | Damon Lees SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-06 |
| Decision Date | 2014-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98004503825050 | K141165 | 000 |
| H98004503824050 | K141165 | 000 |
| H98004503825010 | K141165 | 000 |
| H98004503824010 | K141165 | 000 |
| H980045038210 | K141165 | 000 |
| H980045038200 | K141165 | 000 |