The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5mm Conical Screws.
| Device ID | K050683 |
| 510k Number | K050683 |
| Device Name: | SYNTHES (USA) 3.5MM CONICAL SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson SYNTHES (USA) 1302 WRIGHTS LANE EAST 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 | 2005-03-17 |
| Decision Date | 2005-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794123170 | K050683 | 000 |
| H6794124190 | K050683 | 000 |
| H6794124210 | K050683 | 000 |
| H6794124230 | K050683 | 000 |
| H6794124240 | K050683 | 000 |
| H6794124250 | K050683 | 000 |
| H6794124260 | K050683 | 000 |
| H6794124270 | K050683 | 000 |
| H6794124280 | K050683 | 000 |
| H6794124290 | K050683 | 000 |
| H6794124300 | K050683 | 000 |
| H6794124170 | K050683 | 000 |
| H6794123310 | K050683 | 000 |
| H6794123190 | K050683 | 000 |
| H6794123210 | K050683 | 000 |
| H6794123230 | K050683 | 000 |
| H6794123240 | K050683 | 000 |
| H6794123250 | K050683 | 000 |
| H6794123260 | K050683 | 000 |
| H6794123270 | K050683 | 000 |
| H6794123280 | K050683 | 000 |
| H6794123290 | K050683 | 000 |
| H6794123300 | K050683 | 000 |
| H6794124310 | K050683 | 000 |
| H6792123170 | K050683 | 000 |
| H6792124190 | K050683 | 000 |
| H6792124210 | K050683 | 000 |
| H6792124230 | K050683 | 000 |
| H6792124240 | K050683 | 000 |
| H6792124250 | K050683 | 000 |
| H6792124260 | K050683 | 000 |
| H6792124270 | K050683 | 000 |
| H6792124280 | K050683 | 000 |
| H6792124290 | K050683 | 000 |
| H6792124300 | K050683 | 000 |
| H6792124170 | K050683 | 000 |
| H6792123310 | K050683 | 000 |
| H6792123190 | K050683 | 000 |
| H6792123210 | K050683 | 000 |
| H6792123230 | K050683 | 000 |
| H6792123240 | K050683 | 000 |
| H6792123250 | K050683 | 000 |
| H6792123260 | K050683 | 000 |
| H6792123270 | K050683 | 000 |
| H6792123280 | K050683 | 000 |
| H6792123290 | K050683 | 000 |
| H6792123300 | K050683 | 000 |
| H6792124310 | K050683 | 000 |