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510(k) K802911

A/K SOCKET by Orthomedics — Product Code ISS

K802911 is an FDA 510(k) premarket notification submitted by Orthomedics for the device "A/K SOCKET". The FDA issued a decision of Substantially Equivalent on December 17, 1980. The device falls under product code ISS (Prosthesis, Thigh Socket, External Component), a Class I device regulated under 21 CFR 890.3420. Orthomedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1980
Date Received
November 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Thigh Socket, External Component
Device Class
Class I
Regulation Number
890.3420
Review Panel
PM
Submission Type

Other clearances by Orthomedics

  • K832740 — FEMORAL FRACTURE ORTHOSIS (September 20, 1983)
  • K832741 — JASON CERVICAL ORTHOSIS (September 20, 1983)
  • K832742 — EXTENSION CONTROL KNEE ORTHOSIS (September 20, 1983)
  • K811456 — ORTHO-FRAC KIT (June 12, 1981)
  • K811297 — CERVICAL SUPPORT (May 27, 1981)
  • K811298 — EXECUTIVE COLLAR (May 27, 1981)
  • K810556 — SPINAL EXTENSION BRACE (March 13, 1981)
  • K810555 — SCOLIOSIS ORTHOTIC SYSTEM (March 13, 1981)
  • K810557 — HIP ABDUCTION SPLINT (March 13, 1981)
  • K810554 — LUMBAR FLEXION BRACE (March 13, 1981)

FDA data resources