The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Matrixmandible Plate And Screw System.
Device ID | K082335 |
510k Number | K082335 |
Device Name: | SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM |
Classification | Plate, Bone |
Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
Contact | Amnon Talmor |
Correspondent | Amnon Talmor SYNTHES (USA) 1301 GOSHEN PKWY. 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 | 2008-08-14 |
Decision Date | 2008-11-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H98004503548050 | K082335 | 000 |
H98004503546050 | K082335 | 000 |
H98004503508050 | K082335 | 000 |
H98004503506050 | K082335 | 000 |
H98004503548010 | K082335 | 000 |
H98004503546010 | K082335 | 000 |
H98004503508010 | K082335 | 000 |
H98004503506010 | K082335 | 000 |