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 |