The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) [synthes} Peri-prosthetic Screws.
| Device ID | K041533 |
| 510k Number | K041533 |
| Device Name: | SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Lisa Boyle |
| Correspondent | Lisa Boyle SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-08 |
| Decision Date | 2004-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902221518S0 | K041533 | 000 |
| H679222404S0 | K041533 | 000 |
| H6792224040 | K041533 | 000 |
| H679222402S0 | K041533 | 000 |
| H67904221518S0 | K041533 | 000 |
| H679042215180 | K041533 | 000 |
| H67904221514S0 | K041533 | 000 |
| H679042215140 | K041533 | 000 |
| H67904221512S0 | K041533 | 000 |
| H679042215120 | K041533 | 000 |
| H67904221510S0 | K041533 | 000 |
| H679042215100 | K041533 | 000 |
| H67904221508S0 | K041533 | 000 |
| H679042215080 | K041533 | 000 |
| H679022214580 | K041533 | 000 |
| H67902221458S0 | K041533 | 000 |
| H679022215180 | K041533 | 000 |
| H67902221514S0 | K041533 | 000 |
| H679022215140 | K041533 | 000 |
| H67902221512S0 | K041533 | 000 |
| H679022215120 | K041533 | 000 |
| H67902221510S0 | K041533 | 000 |
| H679022215100 | K041533 | 000 |
| H67902221508S0 | K041533 | 000 |
| H679022215080 | K041533 | 000 |
| H67902221462S0 | K041533 | 000 |
| H679022214620 | K041533 | 000 |
| H67902221460S0 | K041533 | 000 |
| H679022214600 | K041533 | 000 |
| H6792224020 | K041533 | 000 |