The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 2.7 Mm Cannulated Screw And Threaded Washer.
| Device ID | K951304 |
| 510k Number | K951304 |
| Device Name: | SYNTHES 2.7 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 | 1995-03-22 |
| Decision Date | 1995-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794026140 | K951304 | 000 |
| H6794027200 | K951304 | 000 |
| H6794027190 | K951304 | 000 |
| H6794027180 | K951304 | 000 |
| H6794027170 | K951304 | 000 |
| H6794027160 | K951304 | 000 |
| H6794027150 | K951304 | 000 |
| H6794027140 | K951304 | 000 |
| H6794026400 | K951304 | 000 |
| H6794027210 | K951304 | 000 |
| H6794027220 | K951304 | 000 |
| H6794027300 | K951304 | 000 |
| H6794027290 | K951304 | 000 |
| H6794027280 | K951304 | 000 |
| H6794027270 | K951304 | 000 |
| H6794027260 | K951304 | 000 |
| H6794027250 | K951304 | 000 |
| H6794027240 | K951304 | 000 |
| H6794027230 | K951304 | 000 |
| H6794026380 | K951304 | 000 |
| H6794026360 | K951304 | 000 |
| H6794026220 | K951304 | 000 |
| H6794026210 | K951304 | 000 |
| H6794026200 | K951304 | 000 |
| H6794026190 | K951304 | 000 |
| H6794026180 | K951304 | 000 |
| H6794026170 | K951304 | 000 |
| H6794026160 | K951304 | 000 |
| H6794026150 | K951304 | 000 |
| H6794026230 | K951304 | 000 |
| H6794026240 | K951304 | 000 |
| H6794026340 | K951304 | 000 |
| H6794026320 | K951304 | 000 |
| H6794026300 | K951304 | 000 |
| H6794026290 | K951304 | 000 |
| H6794026280 | K951304 | 000 |
| H6794026270 | K951304 | 000 |
| H6794026260 | K951304 | 000 |
| H6794026250 | K951304 | 000 |
| H6794027320 | K951304 | 000 |
| H6794027340 | K951304 | 000 |
| H6792027200 | K951304 | 000 |
| H6792027190 | K951304 | 000 |
| H6792027180 | K951304 | 000 |
| H6792027170 | K951304 | 000 |
| H6792027160 | K951304 | 000 |
| H6792027150 | K951304 | 000 |
| H6792027140 | K951304 | 000 |
| H6792026400 | K951304 | 000 |
| H6792027220 | K951304 | 000 |
| H6792027240 | K951304 | 000 |
| H6792027400 | K951304 | 000 |
| H6792027380 | K951304 | 000 |
| H6792027360 | K951304 | 000 |
| H6792027340 | K951304 | 000 |
| H6792027320 | K951304 | 000 |
| H6792027300 | K951304 | 000 |
| H6792027280 | K951304 | 000 |
| H6792027260 | K951304 | 000 |
| H6792026380 | K951304 | 000 |
| H6792026360 | K951304 | 000 |
| H6792026170 | K951304 | 000 |
| H6792026160 | K951304 | 000 |
| H6792026150 | K951304 | 000 |
| H6792026140 | K951304 | 000 |
| H679419890 | K951304 | 000 |
| H6794027400 | K951304 | 000 |
| H6794027380 | K951304 | 000 |
| H6794027360 | K951304 | 000 |
| H6792026180 | K951304 | 000 |
| H6792026190 | K951304 | 000 |
| H6792026340 | K951304 | 000 |
| H6792026320 | K951304 | 000 |
| H6792026300 | K951304 | 000 |
| H6792026280 | K951304 | 000 |
| H6792026260 | K951304 | 000 |
| H6792026240 | K951304 | 000 |
| H6792026220 | K951304 | 000 |
| H6792026200 | K951304 | 000 |
| H679219890 | K951304 | 000 |