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
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (JDL), ordered by most recent decision date.

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Other Clearances by Devcom, Inc.

K Number Device Name
K902378 CARDIOTHORACIC RULER
K874233 BLOOD PRESSURE SLEEVE W/TUBING
K863313 GRIP STRENGTH DEVICE (GSD)
K861043 SPINAL EXCURSION METER
K850021 ELECTROCARDIOGRAPH-ECG CALIPER