The following data is part of a premarket notification filed by Synthes Inc with the FDA for Synthes Patient Specific Plate.
Device ID | K122647 |
510k Number | K122647 |
Device Name: | SYNTHES PATIENT SPECIFIC PLATE |
Classification | Plate, Bone |
Applicant | SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
Contact | Alan T Haley |
Correspondent | Alan T Haley SYNTHES INC 1301 Goshen Parkway 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 | 2012-08-30 |
Decision Date | 2013-02-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H980SD4801120 | K122647 | 000 |
H980SD4801110 | K122647 | 000 |
H980SD4801100 | K122647 | 000 |
H980SD4801020 | K122647 | 000 |
H980SD4801010 | K122647 | 000 |
H980SD4801000 | K122647 | 000 |