The following data is part of a premarket notification filed by Graftys with the FDA for Grafty Quickset.
| Device ID | K093343 |
| 510k Number | K093343 |
| Device Name: | GRAFTY QUICKSET |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | GRAFTYS 415 RUE CHARLES NICOLAS LEDOUX EIFFEL PARK BAT D Aix En Provence, FR 13854 |
| Contact | Anthony Le Naour |
| Correspondent | Anthony Le Naour GRAFTYS 415 RUE CHARLES NICOLAS LEDOUX EIFFEL PARK BAT D Aix En Provence, FR 13854 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-26 |
| Decision Date | 2010-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556237045 | K093343 | 000 |
| 03760177571402 | K093343 | 000 |
| 03760177571419 | K093343 | 000 |
| 03760177571600 | K093343 | 000 |
| 03760177571617 | K093343 | 000 |
| 03760177571624 | K093343 | 000 |
| 00888867084384 | K093343 | 000 |
| 00888867084407 | K093343 | 000 |
| 00841132177570 | K093343 | 000 |
| 00841132177587 | K093343 | 000 |
| 00841132177594 | K093343 | 000 |
| 00841132177600 | K093343 | 000 |
| 00885556236949 | K093343 | 000 |
| 00885556236994 | K093343 | 000 |
| 03760177571396 | K093343 | 000 |