Burr, Orthopedic
An orthopedic burr is a small, rotating cutting instrument used to grind, shape, or remove bone material during orthopedic surgical procedures, typically attached to a power drill or handpiece. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk and general controls only. Product code HTT falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HTT
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K862529 | HALL STERILE BUR | Jul 15, 1986 | Substantially Equivalent | Hall Surgical, Division of Zimmer, Inc. |
| K821695 | MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER | Jul 20, 1982 | Substantially Equivalent | Micro-Aire Surgical Instruments, Inc. |
| K802598 | CARBIDE CUTTING INSTRUMENT/INTRAARTICU | Nov 19, 1980 | Substantially Equivalent | The Anspach Effort, Inc. |
| K760236 | BUR, SURGICAL CARBIDE | Jul 26, 1976 | Substantially Equivalent | Cutter Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 93 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 93 registration numbers. Click on an entry to view related FDA registrations.