File
An orthopedic file is a handheld rasping instrument used during surgery to smooth, shape, or prepare bone surfaces or cavities, such as when fitting a prosthetic implant. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk subject only to general controls. Product code HTP falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HTP
- 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 |
|---|---|---|---|---|
| K931733 | INTERMEDICS ORTHOPEDICS REAMERS | Jan 26, 1994 | Substantially Equivalent | Intermedics Orthopedics |
| K870842 | SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP | May 27, 1987 | Substantially Equivalent | Warsaw Orthopedic, Inc. |
| K862659 | CONCEPT ARTHROSCOPY RASP | Sep 02, 1986 | Substantially Equivalent | Concept, Inc. |
| K841981 | 4MM & 5MM FILE | Jun 19, 1984 | Substantially Equivalent | Stainless Mfg., Inc. |
| K840492 | SUN-LITE BLUE SLIT | May 09, 1984 | Substantially Equivalent | Suncoast Medical Manufacturers, Inc. |
FEI Numbers
This FDA classification entry is associated with 76 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 76 registration numbers. Click on an entry to view related FDA registrations.