Product Code: HXG
FDA class 1
21 CFR 888.4540
Tamp
Orthopedic
An orthopedic tamp is a flat-ended instrument used to pack, consolidate, or seat bone graft material or to impact an implant component into its intended position during surgery. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk and general controls only. Product code HXG falls under the Orthopedic medical specialty.
510(k)s
1
FEI Numbers
236
Registration Numbers
236
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- HXG
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K841626 | PUNCH | Aug 27, 1984 | Substantially Equivalent | Plastafil, Inc. |
FEI Numbers
This FDA classification entry is associated with 236 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 236 registration numbers. Click on an entry to view related FDA registrations.