The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5mm Locking Attachment Plates.
| Device ID | K083573 |
| 510k Number | K083573 |
| Device Name: | SYNTHES (USA) 3.5MM LOCKING ATTACHMENT 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 | 2008-12-03 |
| Decision Date | 2009-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902120606S0 | K083573 | 000 |
| H67904120601S0 | K083573 | 000 |
| H679041206020 | K083573 | 000 |
| H67904120602S0 | K083573 | 000 |
| H679041206060 | K083573 | 000 |
| H67904120606S0 | K083573 | 000 |
| H679021206010 | K083573 | 000 |
| H67902120601S0 | K083573 | 000 |
| H679021206020 | K083573 | 000 |
| H67902120602S0 | K083573 | 000 |
| H679021206030 | K083573 | 000 |
| H67902120603S0 | K083573 | 000 |
| H679021206040 | K083573 | 000 |
| H67902120604S0 | K083573 | 000 |
| H679021206060 | K083573 | 000 |
| H679041206010 | K083573 | 000 |