The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Sternal Fixation System - Line Extension.
| Device ID | K081700 |
| 510k Number | K081700 |
| Device Name: | SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98004501120050 | K081700 | 000 |
| H98004501110S0 | K081700 | 000 |
| H98004501112010 | K081700 | 000 |
| H98004501112S0 | K081700 | 000 |
| H98004501114010 | K081700 | 000 |
| H98004501114S0 | K081700 | 000 |
| H98004501116010 | K081700 | 000 |
| H98004501116S0 | K081700 | 000 |
| H98004501118010 | K081700 | 000 |
| H98004501118S0 | K081700 | 000 |
| H98004501120010 | K081700 | 000 |
| H98004501120S0 | K081700 | 000 |
| H98004501110050 | K081700 | 000 |
| H98004501112050 | K081700 | 000 |
| H98004501114050 | K081700 | 000 |
| H98004501116050 | K081700 | 000 |
| H98004501118050 | K081700 | 000 |
| H98004501110010 | K081700 | 000 |