Rongeur
A rongeur is a handheld orthopedic instrument with a hinged, sharp-edged cup at its tip used to bite away or remove small pieces of bone or cartilage during surgery. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk subject only to general controls. Product code HTX falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HTX
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K874954 | MANUAL RONGEUR | Dec 30, 1987 | Substantially Equivalent | Solway, Inc. |
| K841621 | BACK RADIUS CUTTER | Sep 20, 1984 | Substantially Equivalent | Plastafil, Inc. |
| K841620 | FRONT RADIUS CUTTER | Sep 20, 1984 | Substantially Equivalent | Plastafil, Inc. |
| K780397 | ORTHOPEDIC FORCEPS | Mar 22, 1978 | Substantially Equivalent | Orthopedic Equipment Co., Inc. |
| K760325 | SURGICAL INSTRUMENTS, ORTHOPEDIC | Aug 03, 1976 | Substantially Equivalent | Depuy, Inc. |
FEI Numbers
This FDA classification entry is associated with 331 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 331 registration numbers. Click on an entry to view related FDA registrations.