The following data is part of a premarket notification filed by Deutschland Surgical, Inc. with the FDA for Vigor Compression Hip Screw System.
| Device ID | K962644 |
| 510k Number | K962644 |
| Device Name: | VIGOR COMPRESSION HIP SCREW SYSTEM |
| Classification | Device, Fixation, Proximal Femoral, Implant |
| Applicant | DEUTSCHLAND SURGICAL, INC. 1222 COMMERCE ST., SUITE 415 Dallas, TX 75202 |
| Contact | Thomas Wolter |
| Correspondent | Thomas Wolter DEUTSCHLAND SURGICAL, INC. 1222 COMMERCE ST., SUITE 415 Dallas, TX 75202 |
| Product Code | JDO |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-08 |
| Decision Date | 1996-09-06 |
| Summary: | summary |