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510(k) K781112

CAST WEDGE, YANCEY by Orthopedic Equipment Co., Inc.

K781112 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "CAST WEDGE, YANCEY". The FDA issued a decision of Substantially Equivalent on July 17, 1978. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1978
Date Received
July 3, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Orthopedic Equipment Co., Inc.

  • K834035 — UNIVERSAL SELF-ALIGNING ACETABULAR COM (June 19, 1984)
  • K841189 — OEC/REZAIAN SPINAL FIXATOR (May 16, 1984)
  • K800530 — SCHLEIN TRI-SURFACE ANKLE (April 2, 1980)
  • K781445 — SPREADER (September 27, 1979)
  • K790247 — TOURNIQUET TEST GAGE (February 26, 1979)
  • K790209 — FILTER SYSTEM, ALTNER DISPOSABLE (February 26, 1979)
  • K781444 — OUTRIGGER DISTRACTION UNIT (September 27, 1978)
  • K781446 — C RING CLINCHER (September 27, 1978)
  • K781448 — HARRINGTON HOOK CLAMP (September 27, 1978)
  • K781447 — THREADED ROD CLAMP (September 27, 1978)

FDA data resources