The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Depuy Synthes 3.5mm Intrapelvic Acetabular System.
| Device ID | K221809 |
| 510k Number | K221809 |
| Device Name: | DePuy Synthes 3.5mm Intrapelvic Acetabular System |
| Classification | Plate, Fixation, Bone |
| Applicant | DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Alyssa Bryan |
| Correspondent | Alyssa Bryan DePuy Synthes 1301 Goshen Parkway 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 | 2022-06-22 |
| Decision Date | 2022-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612334227218 | K221809 | 000 |
| 10886982310903 | K221809 | 000 |
| 10886982310910 | K221809 | 000 |
| 10886982310927 | K221809 | 000 |
| 10886982310934 | K221809 | 000 |
| 10886982310941 | K221809 | 000 |
| 10886982310958 | K221809 | 000 |
| 10886982310965 | K221809 | 000 |
| 07612334227171 | K221809 | 000 |
| 07612334227188 | K221809 | 000 |
| 07612334227195 | K221809 | 000 |
| 07612334227201 | K221809 | 000 |
| 10886982310897 | K221809 | 000 |