Product Code: HTW
FDA class 1
21 CFR 888.4540
Bit, Drill
Orthopedic
A drill bit is a rotary cutting tool used in orthopedic surgery to create holes in bone for the placement of screws, pins, wires, or other fixation hardware. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HTW falls under the Orthopedic medical specialty.
510(k)s
11
FEI Numbers
567
Registration Numbers
567
Unique Applicants
11
Years Active
34
Basic Information
- Product Code
- HTW
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K151661 | Renovo Life Hard Carbon Coated Drill Bit | Jan 15, 2016 | Substantially Equivalent | Renovo Life LLC |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | Dec 22, 1994 | Substantially Equivalent | HAND BIOMECHANICS LAB, INC. |
| K930339 | REAMER BIT | Aug 06, 1993 | Substantially Equivalent | NEOLIGAMENTS, LTD. |
| K915692 | CANNULATED DRILL BIT | Jan 16, 1992 | Substantially Equivalent | W.L. GORE & ASSOCIATES,INC |
| K892903 | MITEK ANCHOR DRILL | Oct 06, 1989 | Substantially Equivalent | MITEK SURGICAL PRODUCTS, INC. |
| K870217 | FEMORAL CEMENT REMOVAL INSTRUMENTS | Feb 06, 1987 | Substantially Equivalent | KENNETH J. HOEK, M.D., INC. |
| K863147 | GLENOID DRILL | Sep 05, 1986 | Substantially Equivalent | BOWEN & COMPANY, INC. |
| K841629 | DRILL BIT | Aug 27, 1984 | Substantially Equivalent | PLASTAFIL, INC. |
| K834229 | BONE PLUGGING TOOL | Jan 10, 1984 | Substantially Equivalent | STANDARD SURGICAL |
| K831712 | SURGICAL DRILL BITS | Jul 07, 1983 | Substantially Equivalent | MEDICAL SPECIALISTS IN PACKAGING |
| K820226 | UNIVERSALL DRILL GUIDE | Feb 04, 1982 | Substantially Equivalent | ORTHO PARED INSTRUMENTS, INC. |
FEI Numbers
This FDA classification entry is associated with 567 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 567 registration numbers. Click on an entry to view related FDA registrations.