The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Ace-fischer(r), Tempfix(r), Hoffman Classic(tm) External Fixators.
| Device ID | K112218 |
| 510k Number | K112218 |
| Device Name: | ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Suzana Otano |
| Correspondent | Suzana Otano DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-02 |
| Decision Date | 2011-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868003066 | K112218 | 000 |
| 00887868003059 | K112218 | 000 |
| 00887868001598 | K112218 | 000 |
| 00887868003042 | K112218 | 000 |
| 00887868003035 | K112218 | 000 |
| 00887868001567 | K112218 | 000 |
| 00887868001550 | K112218 | 000 |
| 00887868001420 | K112218 | 000 |