Knife, Orthopedic
An orthopedic knife is a surgical cutting instrument with a fixed blade designed for incising tissue during orthopedic procedures. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk subject to general controls. Product code HTS falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HTS
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K930507 | CUSTOM ORTHOPAEDIC TRAYS (PACKS) | Feb 22, 1994 | Substantially Equivalent | Associated Medical Products Co. |
| K933921 | ACUFLEX DISPOSABLE KNIVES | Jan 26, 1994 | Substantially Equivalent | Acufex Microsurgical, Inc. |
| K882525 | SPINAL MICROKNIFE | Sep 22, 1988 | Substantially Equivalent | Karlin Technology, Inc. |
| K873714 | BANANA KNIFE, DISPOSABLE #TM-1612 | Nov 02, 1987 | Substantially Equivalent | Arthropedics, Inc. |
| K873713 | TRIANGULAR KNIFE, DISPOSABLE #TM-1611 | Nov 02, 1987 | Substantially Equivalent | Arthropedics, Inc. |
| K873711 | RETROGRADE KNIFE, DISPOSABLE #TM-1613 | Nov 02, 1987 | Substantially Equivalent | Arthropedics, Inc. |
| K873712 | STANDARD KNIFE, DISPOSABLE #TM-1610 | Oct 15, 1987 | Substantially Equivalent | Arthropedics, Inc. |
| K842820 | ARTHROSCOPY KNIVES | Aug 14, 1984 | Substantially Equivalent | Medtech Industries, Inc. |
| K771851 | ARTHROSCOPE OPERATIVE KNIFE SET | Oct 27, 1977 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
FEI Numbers
This FDA classification entry is associated with 117 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 117 registration numbers. Click on an entry to view related FDA registrations.