The following data is part of a premarket notification filed by Normed Medizin-technik Gmbh with the FDA for Normed Ankle Fix System 4.0 And Normed Ankle Fix Plus System 4.0.
| Device ID | K123347 |
| 510k Number | K123347 |
| Device Name: | NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 |
| Classification | Plate, Fixation, Bone |
| Applicant | NORMED MEDIZIN-TECHNIK GMBH 8708 CAPEHART COVE Austin, TX 78733 |
| Contact | David C Furr |
| Correspondent | David C Furr NORMED MEDIZIN-TECHNIK GMBH 8708 CAPEHART COVE Austin, TX 78733 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-31 |
| Decision Date | 2013-08-02 |
| Summary: | summary |