The following data is part of a premarket notification filed by Normed Medizin-technik Gmbh with the FDA for Normed Pellegrin Calcaneus Stop Screw.
| Device ID | K133035 |
| 510k Number | K133035 |
| Device Name: | NORMED PELLEGRIN CALCANEUS STOP SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | NORMED MEDIZIN-TECHNIK GMBH 8708 CAPEHART COVE Austin, TX 78733 |
| Contact | Dalene Binkley |
| Correspondent | Dalene Binkley NORMED MEDIZIN-TECHNIK GMBH 8708 CAPEHART COVE Austin, TX 78733 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-27 |
| Decision Date | 2013-12-13 |
| Summary: | summary |