HTW — Bit, Drill Class I
FDA Device Classification
Classification Details
- Product Code
- HTW
- Device Class
- Class I
- Regulation Number
- 888.4540
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K151661 | renovo life | Renovo Life Hard Carbon Coated Drill Bit | January 15, 2016 |
| K942906 | hand biomechanics lab | AGEE-WRISTJACK PRE-DRILL KIT | December 22, 1994 |
| K930339 | neoligaments | REAMER BIT | August 6, 1993 |
| K915692 | w.l. gore and associates | CANNULATED DRILL BIT | January 16, 1992 |
| K892903 | mitek surgical products | MITEK ANCHOR DRILL | October 6, 1989 |
| K870217 | kenneth j. hoek, m.d | FEMORAL CEMENT REMOVAL INSTRUMENTS | February 6, 1987 |
| K863147 | bowen and company | GLENOID DRILL | September 5, 1986 |
| K841629 | plastafil | DRILL BIT | August 27, 1984 |
| K834229 | standard surgical | BONE PLUGGING TOOL | January 10, 1984 |
| K831712 | medical specialists in packaging | SURGICAL DRILL BITS | July 7, 1983 |
| K820226 | ortho pared instruments | UNIVERSALL DRILL GUIDE | February 4, 1982 |