The following data is part of a premarket notification filed by Surgical Implant Generation Network (sign) with the FDA for Sign Hip Construct (shc), Model: 701.
| Device ID | K083582 |
| 510k Number | K083582 |
| Device Name: | SIGN HIP CONSTRUCT (SHC), MODEL: 701 |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SURGICAL IMPLANT GENERATION NETWORK (SIGN) 451 HILLS ST., SUITE B Richland, WA 99354 |
| Contact | Douglas J Donnelly |
| Correspondent | Douglas J Donnelly SURGICAL IMPLANT GENERATION NETWORK (SIGN) 451 HILLS ST., SUITE B Richland, WA 99354 |
| Product Code | KTT |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HSB |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-04 |
| Decision Date | 2009-08-26 |
| Summary: | summary |