The following data is part of a premarket notification filed by Dolphin Medical Technologies, Inc. with the FDA for Drg Large Screw System.
| Device ID | K973810 |
| 510k Number | K973810 |
| Device Name: | DRG LARGE SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | DOLPHIN MEDICAL TECHNOLOGIES, INC. 5959 CATTLEMEN LN. Sarasota, FL 34232 |
| Contact | Mark G Urbanski |
| Correspondent | Mark G Urbanski DOLPHIN MEDICAL TECHNOLOGIES, INC. 5959 CATTLEMEN LN. Sarasota, FL 34232 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-07 |
| Decision Date | 1998-01-05 |
| Summary: | summary |