Hook, Bone
Bone Hook is a manual surgical instrument with a curved or hooked end used in orthopedic and general surgical procedures to retract, manipulate, or reposition bone fragments or skeletal structures during open surgical access, providing the surgeon with mechanical advantage and controlled bone handling. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIK, regulated under 21 CFR 878.4800, within the General, Plastic Surgery medical specialty.
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Basic Information
- Product Code
- KIK
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K770759 | HOOK HOLLER | Apr 29, 1977 | Substantially Equivalent | Depuy, Inc. |
FEI Numbers
This FDA classification entry is associated with 115 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 115 registration numbers. Click on an entry to view related FDA registrations.