The following data is part of a premarket notification filed by Normed Nedizin Technik Gmbh with the FDA for Normed Vario Subtalar Screw.
| Device ID | K140962 |
| 510k Number | K140962 |
| Device Name: | NORMED VARIO SUBTALAR SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | NORMED NEDIZIN TECHNIK GMBH 8708 CAPEHART COVE Austin, TX 78733 |
| Contact | David Furr |
| Correspondent | David Furr NORMED NEDIZIN 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 | 2014-04-15 |
| Decision Date | 2014-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024110793 | K140962 | 000 |
| 00889024110670 | K140962 | 000 |
| 00889024110687 | K140962 | 000 |
| 00889024110694 | K140962 | 000 |
| 00889024110700 | K140962 | 000 |
| 00889024110717 | K140962 | 000 |
| 00889024110724 | K140962 | 000 |
| 00889024110731 | K140962 | 000 |
| 00889024110748 | K140962 | 000 |
| 00889024110755 | K140962 | 000 |
| 00889024110762 | K140962 | 000 |
| 00889024110779 | K140962 | 000 |
| 00889024110786 | K140962 | 000 |
| 00889024110663 | K140962 | 000 |