The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cannulated Angle Blade Plate (cabp) System.
| Device ID | K974537 |
| 510k Number | K974537 |
| Device Name: | SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-03 |
| Decision Date | 1998-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679237043S0 | K974537 | 000 |
| H679237106S0 | K974537 | 000 |
| H679237123S0 | K974537 | 000 |
| H679237124S0 | K974537 | 000 |
| H679237125S0 | K974537 | 000 |
| H679237143S0 | K974537 | 000 |
| H679237144S0 | K974537 | 000 |
| H679237145S0 | K974537 | 000 |
| H679237146S0 | K974537 | 000 |
| H679437043S0 | K974537 | 000 |
| H679237105S0 | K974537 | 000 |
| H679237104S0 | K974537 | 000 |
| H679237044S0 | K974537 | 000 |
| H679237053S0 | K974537 | 000 |
| H679237054S0 | K974537 | 000 |
| H679237063S0 | K974537 | 000 |
| H679237064S0 | K974537 | 000 |
| H679237083S0 | K974537 | 000 |
| H679237084S0 | K974537 | 000 |
| H679237085S0 | K974537 | 000 |
| H679237086S0 | K974537 | 000 |
| H679437044S0 | K974537 | 000 |
| H679437053S0 | K974537 | 000 |
| H679437054S0 | K974537 | 000 |
| H679437124S0 | K974537 | 000 |
| H679437125S0 | K974537 | 000 |
| H679437126S0 | K974537 | 000 |
| H679437143S0 | K974537 | 000 |
| H679437144S0 | K974537 | 000 |
| H679437145S0 | K974537 | 000 |
| H679437146S0 | K974537 | 000 |
| H6792181500 | K974537 | 000 |
| H679237103S0 | K974537 | 000 |
| H679437123S0 | K974537 | 000 |
| H679437106S0 | K974537 | 000 |
| H679437063S0 | K974537 | 000 |
| H679437064S0 | K974537 | 000 |
| H679437083S0 | K974537 | 000 |
| H679437084S0 | K974537 | 000 |
| H679437085S0 | K974537 | 000 |
| H679437086S0 | K974537 | 000 |
| H679437103S0 | K974537 | 000 |
| H679437104S0 | K974537 | 000 |
| H679437105S0 | K974537 | 000 |
| H679237126S0 | K974537 | 000 |