Corkscrew
A corkscrew is a handheld orthopedic surgical instrument used to engage and extract bone or implant material by means of a spiral threaded tip, commonly used in arthroscopic or open procedures to retrieve or anchor tissue. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk and general controls only. Product code HWI falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HWI
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K875166 | PHARMASEAL STERILE UMBILICAL CORD CLAMP | Mar 02, 1988 | Substantially Equivalent | Baxter Healthcare Corp |
FEI Numbers
This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.