Spatula, Orthopedic
An orthopedic spatula is a flat-bladed instrument used in surgical procedures to spread, lift, or manipulate tissue or bone surfaces; in the orthopedic context, it may be used to apply bone cement or to retract soft tissues. It is classified as an FDA Class 1 device under 21 CFR 878.4800, indicating low risk and general controls only. Product code HXR falls under the General and Plastic Surgery medical specialty.
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Basic Information
- Product Code
- HXR
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- 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 |
|---|---|---|---|---|
| K983882 | MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 | Mar 15, 1999 | Substantially Equivalent | Micro-Medical Devices, Inc. |
| K873387 | VIDEO ARTHROSCOPE, 1.7MM X 55 MM | Nov 25, 1987 | Substantially Equivalent | Arthropedics, Inc. |
| K872281 | RAYLOR FUSION FUNNEL | Nov 02, 1987 | Substantially Equivalent | Cedar Surgical, Inc. |
| K853436 | H-H HUNTER PASSIVE TENDON IMPLANT | Oct 16, 1985 | Substantially Equivalent | Holter-Hausner Intl. |
FEI Numbers
This FDA classification entry is associated with 55 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 55 registration numbers. Click on an entry to view related FDA registrations.