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510(k) K812064

POLI-AXIAL KNEE CAGE by Generation II Orthotics, Inc. — Product Code ITM

K812064 is an FDA 510(k) premarket notification submitted by Generation II Orthotics, Inc. for the device "POLI-AXIAL KNEE CAGE". The FDA issued a decision of Substantially Equivalent on August 13, 1981. The device falls under product code ITM (Cage, Knee), a Class I device regulated under 21 CFR 890.3475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1981
Date Received
July 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cage, Knee
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances for product code ITM

  • K832742 — EXTENSION CONTROL KNEE ORTHOSIS (September 20, 1983)
  • K770900 — CAST BRWM, FRACTURE (July 21, 1977)
  • K770899 — FRACTURE CAST BRACE, POLY (July 21, 1977)
  • K760573 — IMPROVED KNEE DRESSING (October 5, 1976)

FDA data resources