The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sacral Bar System.
| Device ID | K001720 |
| 510k Number | K001720 |
| Device Name: | SYNTHES SACRAL BAR SYSTEM |
| Classification | Pin, Fixation, Threaded |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-06 |
| Decision Date | 2000-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792967590 | K001720 | 000 |
| H6792967580 | K001720 | 000 |
| H6792967570 | K001720 | 000 |
| H981SD4960020 | K001720 | 000 |
| H981SD4960010 | K001720 | 000 |
| H6792967660 | K001720 | 000 |
| H6792967630 | K001720 | 000 |
| H679199936S0 | K001720 | 000 |
| H679199933S0 | K001720 | 000 |