The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 6.5 Mm Cancellous Screws.
| Device ID | K061621 |
| 510k Number | K061621 |
| Device Name: | SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Deborah L Jackson |
| Correspondent | Deborah L Jackson SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-12 |
| Decision Date | 2006-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792182300 | K061621 | 000 |
| H6794180100 | K061621 | 000 |
| H6794180110 | K061621 | 000 |
| H6794180120 | K061621 | 000 |
| H6794180130 | K061621 | 000 |
| H6794180140 | K061621 | 000 |
| H6794180150 | K061621 | 000 |
| H6794180160 | K061621 | 000 |
| H6794180170 | K061621 | 000 |
| H6794180180 | K061621 | 000 |
| H6794180190 | K061621 | 000 |
| H6794182150 | K061621 | 000 |
| H6794182200 | K061621 | 000 |
| H6794182250 | K061621 | 000 |
| H6794182300 | K061621 | 000 |
| H6792182150 | K061621 | 000 |
| H6792182200 | K061621 | 000 |
| H6792182250 | K061621 | 000 |
| H6794180090 | K061621 | 000 |