The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sterile 3.0 Mm Cannulated Screw And Threaded Washer.
| Device ID | K962823 |
| 510k Number | K962823 |
| Device Name: | SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-19 |
| Decision Date | 1996-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792027290 | K962823 | 000 |
| H6792026110 | K962823 | 000 |
| H6792026100 | K962823 | 000 |
| H6792026090 | K962823 | 000 |
| H6792026080 | K962823 | 000 |
| H6794026130 | K962823 | 000 |
| H6794026120 | K962823 | 000 |
| H6794026110 | K962823 | 000 |
| H6794026100 | K962823 | 000 |
| H6794026090 | K962823 | 000 |
| H6792026120 | K962823 | 000 |
| H6792026130 | K962823 | 000 |
| H6792027270 | K962823 | 000 |
| H6792027250 | K962823 | 000 |
| H6792027230 | K962823 | 000 |
| H6792027210 | K962823 | 000 |
| H6792026290 | K962823 | 000 |
| H6792026270 | K962823 | 000 |
| H6792026250 | K962823 | 000 |
| H6792026230 | K962823 | 000 |
| H6792026210 | K962823 | 000 |
| H6794026080 | K962823 | 000 |