The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 2.7mm/ 3.5mm Lcp Anterolateral Distal Tibia Plates.
Device ID | K092812 |
510k Number | K092812 |
Device Name: | SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES |
Classification | Plate, Fixation, Bone |
Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
Contact | Karl J Nittinger |
Correspondent | Karl J Nittinger 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 | 2009-09-14 |
Decision Date | 2010-05-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H679SD2414530 | K092812 | 000 |
H679SD2414520 | K092812 | 000 |
H679SD2414490 | K092812 | 000 |
H679SD2414480 | K092812 | 000 |
H679SD2414450 | K092812 | 000 |
H679SD2414440 | K092812 | 000 |
H679SD2414430 | K092812 | 000 |
H679SD2414420 | K092812 | 000 |