FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAST BLOCK
K Number: K781082
·
Decision Jul 7, 1978
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
12
Applicant Total
45
Review Days
8
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Basic Information
- Device Name
- CAST BLOCK
- K Number
- K781082
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Orthopedic Equipment Co., Inc.
- Date Received
- June 29, 1978
- Decision Date
- July 7, 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.
ORTHOVISION TABLE
FDA 510(k)
FDA Class 1
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SCHOLTEN FRAME
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ORTHO-J, INC. BEK-JS-004
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WILLIAMS BELT & BOOT
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K ORTHOPEDIC TABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Orthopedic Equipment Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K834035 | UNIVERSAL SELF-ALIGNING ACETABULAR COM | Jun 19, 1984 | Substantially Equivalent |
| K841189 | OEC/REZAIAN SPINAL FIXATOR | May 16, 1984 | Substantially Equivalent |
| K800530 | SCHLEIN TRI-SURFACE ANKLE | Apr 2, 1980 | Substantially Equivalent |
| K781445 | SPREADER | Sep 27, 1979 | Substantially Equivalent |
| K790247 | TOURNIQUET TEST GAGE | Feb 26, 1979 | Substantially Equivalent |
| K790209 | FILTER SYSTEM, ALTNER DISPOSABLE | Feb 26, 1979 | Substantially Equivalent |
| K781450 | DRIVERS | Sep 27, 1978 | Substantially Equivalent |
| K781444 | OUTRIGGER DISTRACTION UNIT | Sep 27, 1978 | Substantially Equivalent |
| K781451 | FLAT WRENCH | Sep 27, 1978 | Substantially Equivalent |
| K781447 | THREADED ROD CLAMP | Sep 27, 1978 | Substantially Equivalent |