Extractor
An extractor is a handheld orthopedic surgical instrument used to remove implants, prosthetic components, or hardware from bone during revision surgery or hardware removal procedures. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HWB falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HWB
- 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 |
|---|---|---|---|---|
| K873710 | MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350 | Nov 02, 1987 | Substantially Equivalent | Arthropedics, Inc. |
| K870844 | SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR | Mar 13, 1987 | Substantially Equivalent | Warsaw Orthopedic, Inc. |
| K870083 | FERRAY EXTRACTOR | Feb 26, 1987 | Substantially Equivalent | Terray Manufacturing, Inc. |
| K801327 | THE EXTRACTOR I TM | Jun 09, 1980 | Substantially Equivalent | The Anspach Effort, Inc. |
| K780300 | HIP PLATE REMOVAL INSTRUMENT | Feb 28, 1978 | Substantially Equivalent | Richard'S Medical Equip., Inc. |
FEI Numbers
This FDA classification entry is associated with 277 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 277 registration numbers. Click on an entry to view related FDA registrations.