FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
JOINT MEASUREMENT INDICATOR
K Number: K861264
·
Decision Apr 15, 1986
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
44
Applicant Total
6
Review Days
11
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Basic Information
- Device Name
- JOINT MEASUREMENT INDICATOR
- K Number
- K861264
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3320
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Devcom, Inc.
- Date Received
- April 4, 1986
- Decision Date
- April 15, 1986
- Product Code
- JDL
- 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 |
|---|---|---|---|
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | FDA class 3 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDL), ordered by most recent decision date.
VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES
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FDA Class 3
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DYNASTY ACETABULAR SYSTEM
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FDA Class 3
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DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER
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PROFEMUR RENAISSANCE HIP STEM
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FDA Class 3
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CONSERVE TOTAL FEMORAL HEAD
FDA 510(k)
FDA Class 3
·Orthopedic
M2A/C2A ACETABULAR SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
Other Clearances by Devcom, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902378 | CARDIOTHORACIC RULER | Jun 14, 1990 | Substantially Equivalent |
| K874233 | BLOOD PRESSURE SLEEVE W/TUBING | Mar 22, 1988 | Substantially Equivalent |
| K863313 | GRIP STRENGTH DEVICE (GSD) | Sep 9, 1986 | Substantially Equivalent |
| K861043 | SPINAL EXCURSION METER | Mar 28, 1986 | Substantially Equivalent |
| K850021 | ELECTROCARDIOGRAPH-ECG CALIPER | Feb 8, 1985 | Substantially Equivalent |