The following data is part of a premarket notification filed by Genesis Orthopedics, Inc. with the FDA for Go Universalk-wire Fluted Drill.
| Device ID | K954543 |
| 510k Number | K954543 |
| Device Name: | GO UNIVERSALK-WIRE FLUTED DRILL |
| Classification | Pin, Fixation, Smooth |
| Applicant | GENESIS ORTHOPEDICS, INC. 169 BENT ST. Cambridge, MA 02141 |
| Contact | Douglas Fogg |
| Correspondent | Douglas Fogg GENESIS ORTHOPEDICS, INC. 169 BENT ST. Cambridge, MA 02141 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-28 |
| Decision Date | 1995-12-08 |