FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
K Number: K943873
·
Decision Apr 26, 1995
Classifications
1
FEI Numbers
1140
Registration Numbers
1140
Same Product Code
57
Applicant Total
60
Review Days
260
Basic Information
- Device Name
- ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
- K Number
- K943873
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ORTHOMET, INC.
- Date Received
- August 9, 1994
- Decision Date
- April 26, 1995
- Product Code
- LXH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | FDA class 1 | Orthopedic |
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