The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 5.0/7.3 Mm Cannulated Locking Screws.
| Device ID | K040765 |
| 510k Number | K040765 |
| Device Name: | SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS |
| Classification | Pin, Fixation, Threaded |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-25 |
| Decision Date | 2004-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679022071450 | K040765 | 000 |
| H679022070250 | K040765 | 000 |
| H679022070200 | K040765 | 000 |
| H679022051450 | K040765 | 000 |
| H679022051400 | K040765 | 000 |
| H679022051350 | K040765 | 000 |
| H679022051300 | K040765 | 000 |
| H679022051250 | K040765 | 000 |
| H679022051200 | K040765 | 000 |
| H679022051150 | K040765 | 000 |
| H679022051100 | K040765 | 000 |
| H679022051050 | K040765 | 000 |
| H679022070300 | K040765 | 000 |
| H679022070350 | K040765 | 000 |
| H679022071400 | K040765 | 000 |
| H679022071350 | K040765 | 000 |
| H679022071300 | K040765 | 000 |
| H679022071250 | K040765 | 000 |
| H679022071200 | K040765 | 000 |
| H679022071150 | K040765 | 000 |
| H679022071100 | K040765 | 000 |
| H679022071050 | K040765 | 000 |
| H679022071000 | K040765 | 000 |
| H679022070450 | K040765 | 000 |
| H679022070400 | K040765 | 000 |
| H679022051000 | K040765 | 000 |