The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Mini External Fixator.
Device ID | K961350 |
510k Number | K961350 |
Device Name: | SYNTHES MINI EXTERNAL FIXATOR |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Angela Silvestri |
Correspondent | Angela Silvestri SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-05 |
Decision Date | 1996-06-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H6792927080 | K961350 | 000 |
H6793959020 | K961350 | 000 |
H6793953040 | K961350 | 000 |
H6793953020 | K961350 | 000 |
H6793951390 | K961350 | 000 |