The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Compression Cerclage Gundolf Ccg-gf.
| Device ID | K973098 |
| 510k Number | K973098 |
| Device Name: | COMPRESSION CERCLAGE GUNDOLF CCG-GF |
| Classification | Cerclage, Fixation |
| Applicant | PLUS ORTHOPEDICS 835 CORTEZ LN. Forest City, CA 94404 |
| Contact | Hartmut Loch |
| Correspondent | Hartmut Loch PLUS ORTHOPEDICS 835 CORTEZ LN. Forest City, CA 94404 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-19 |
| Decision Date | 1997-10-27 |
| Summary: | summary |