Instrument, Bending Or Contouring
A bending or contouring instrument is a handheld orthopedic tool used to bend, shape, or contour fixation plates, rods, or other hardware to match the patient's individual anatomy prior to implantation. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HXP falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HXP
- 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 |
|---|---|---|---|---|
| K872858 | WILLIAMS VERTEBRAL SPREADER | Oct 15, 1987 | Substantially Equivalent | Ace Medical Co. |
| K800733 | DOUBLE-EDGE CURETTE | Apr 08, 1980 | Substantially Equivalent | Stainless Mfg., Inc. |
| K800732 | MENISCOTOME | Apr 08, 1980 | Substantially Equivalent | Stainless Mfg., Inc. |
| K800731 | MENISCAL SAW | Apr 08, 1980 | Substantially Equivalent | Stainless Mfg., Inc. |
| K800730 | RETROGRADE KNIFE | Apr 08, 1980 | Substantially Equivalent | Stainless Mfg., Inc. |
FEI Numbers
This FDA classification entry is associated with 162 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 162 registration numbers. Click on an entry to view related FDA registrations.