Instrument, Compression
A compression instrument is a handheld orthopedic surgical tool used to apply compressive force across a bone fracture or osteotomy site, facilitating bone contact and promoting healing during fixation procedures. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HWN falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HWN
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K854241 | AOT EXTERNAL COMPRESS DEVICE | Mar 03, 1986 | Substantially Equivalent | Advanced Ortho-Technology, Inc. |
| K792253 | ARICULATED TENSION DEVICE SYNTHES TEN | Dec 05, 1979 | Substantially Equivalent | Synthes (Usa) |
| K770349 | RIGID TEACHING ATTACHMENT | Mar 07, 1977 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
| K760970 | FLORIO CPC BAND | Nov 23, 1976 | Substantially Equivalent | Richard'S Medical Equip., Inc. |
FEI Numbers
This FDA classification entry is associated with 167 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 167 registration numbers. Click on an entry to view related FDA registrations.