FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARTHROSTRESS
K Number: K772321
·
Decision Jan 3, 1978
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
12
Applicant Total
5
Review Days
15
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Basic Information
- Device Name
- ARTHROSTRESS
- K Number
- K772321
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Mtd, Inc.
- Date Received
- December 19, 1977
- Decision Date
- January 3, 1978
- Product Code
- JEB
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| JEB | Table, Surgical With Orthopedic Accessories, Manual | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JEB), ordered by most recent decision date.
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OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION
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Other Clearances by Mtd, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063439 | MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS | Jan 22, 2007 | Substantially Equivalent |
| K833559 | ARMBOARD | Jan 3, 1984 | Substantially Equivalent |
| K791374 | THE MTD VARA SET CASETTE HOLDER | Sep 7, 1979 | Substantially Equivalent |
| K771659 | PATIENT RESTRAINT SYSTEM | Sep 30, 1977 | Substantially Equivalent |