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510(k) K761036

WILSON SPINAL FRAME by Orthopedic Equipment Co., Inc. — Product Code HSQ

K761036 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "WILSON SPINAL FRAME". The FDA issued a decision of Substantially Equivalent on December 16, 1976. The device falls under product code HSQ (Belt, Pelvic, Traction), a Class I device regulated under 21 CFR 888.5890. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1976
Date Received
November 15, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Belt, Pelvic, Traction
Device Class
Class I
Regulation Number
888.5890
Review Panel
OR
Submission Type

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)
  • K781447 — THREADED ROD CLAMP (September 27, 1978)
  • K781446 — C RING CLINCHER (September 27, 1978)
  • K781448 — HARRINGTON HOOK CLAMP (September 27, 1978)

FDA data resources