The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Lcp Ankle Arthrodesis Plates.
Device ID | K061940 |
510k Number | K061940 |
Device Name: | SYNTHES LCP ANKLE ARTHRODESIS PLATES |
Classification | Plate, Fixation, Bone |
Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
Contact | Sheri L Musgnung |
Correspondent | Sheri L Musgnung SYNTHES (USA) 1301 GOSHEN PKWY 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 | 2006-07-10 |
Decision Date | 2006-09-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H67902100033S0 | K061940 | 000 |
H67902100032S0 | K061940 | 000 |