Chisel (Osteotome)
A chisel (osteotome) is a surgical hand instrument with a beveled cutting edge used to cut, shape, or split bone during orthopedic, craniofacial, or reconstructive surgical procedures by applying manual or mallet-driven force. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls and not requiring premarket notification. Product code KDG is regulated under 21 CFR 878.4820 in the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KDG
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
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 |
|---|---|---|---|---|
| K952678 | STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT | Jul 10, 1995 | Substantially Equivalent | Avail-Southwest Division |
| K952200 | OMNI-JUG | Jun 29, 1995 | Substantially Equivalent | Waterstone Medical, Inc. |
| K894785 | SURGICAL CHISEL/OSTEOTOME | Aug 18, 1989 | Substantially Equivalent | Fdt Precision Machine Co., Inc. |
| K891471 | SIL-MED WASTE FLUID DUMP BAG | Aug 15, 1989 | Substantially Equivalent | Sil-Med Corp. |
| K872947 | POREX QUALITY PLASTIC SURGERY INSTRUMENTS | Aug 21, 1987 | Substantially Equivalent | Porex Medical |
| K872092 | OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 | Jun 23, 1987 | Substantially Equivalent | Military Engineering, Inc. |
| K842824 | CHERMEL BONE CHISELS | Aug 02, 1984 | Substantially Equivalent | Cher Mel Corp. |
| K772376 | NEIVERT OSTEOTOME | Mar 09, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K772374 | SILVER OSTEOTOME | Mar 09, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K772373 | ANDERSON-NEIVERT OSTEOTOME | Mar 09, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K780135 | CEMENT EXTRACTION INSTRUMENT SET | Jan 31, 1978 | Substantially Equivalent | Orthopedic Equipment Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 87 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 87 registration numbers. Click on an entry to view related FDA registrations.