The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Rib Fixation System.
| Device ID | K081623 |
| 510k Number | K081623 |
| Device Name: | SYNTHES RIB FIXATION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Amnon Talmor |
| Correspondent | Amnon Talmor 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 | 2008-06-10 |
| Decision Date | 2008-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98004501042050 | K081623 | 000 |
| H98004501018010 | K081623 | 000 |
| H98004501016010 | K081623 | 000 |
| H980045010120 | K081623 | 000 |
| H980045010110 | K081623 | 000 |
| H980045010100 | K081623 | 000 |
| H980045010090 | K081623 | 000 |
| H980045010080 | K081623 | 000 |
| H980045010070 | K081623 | 000 |
| H980045010060 | K081623 | 000 |
| H980045010050 | K081623 | 000 |
| H980045010040 | K081623 | 000 |
| H980045010030 | K081623 | 000 |
| H980045010020 | K081623 | 000 |
| H98004501020010 | K081623 | 000 |
| H98004501022010 | K081623 | 000 |
| H98004501040050 | K081623 | 000 |
| H98004501028050 | K081623 | 000 |
| H98004501026050 | K081623 | 000 |
| H98004501024050 | K081623 | 000 |
| H98004501022050 | K081623 | 000 |
| H98004501020050 | K081623 | 000 |
| H98004501018050 | K081623 | 000 |
| H98004501016050 | K081623 | 000 |
| H98004501042010 | K081623 | 000 |
| H98004501040010 | K081623 | 000 |
| H98004501028010 | K081623 | 000 |
| H98004501026010 | K081623 | 000 |
| H98004501024010 | K081623 | 000 |
| H980045010010 | K081623 | 000 |