The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Spherical Washers.
Device ID | K052483 |
510k Number | K052483 |
Device Name: | SYNTHES (USA) SPHERICAL WASHERS |
Classification | Washer, Bolt, Nut, Non-spinal, Metallic |
Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
Contact | Lisa M Boyle |
Correspondent | Lisa M Boyle SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
Product Code | NDG |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-09 |
Decision Date | 2005-11-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H679219953S0 | K052483 | 000 |
H679219952S0 | K052483 | 000 |
H679419953S0 | K052483 | 000 |