Home / 510(k) Clearances / K780763

510(k) K780763

ENTRAX TRACTION UNIT by Orthopedic Equipment Co., Inc. — Product Code HSR

K780763 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "ENTRAX TRACTION UNIT". The FDA issued a decision of Substantially Equivalent on May 16, 1978. The device falls under product code HSR (Unit, Traction, Hip, Non-Powered, Non-Penetrating), 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
May 16, 1978
Date Received
May 8, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Traction, Hip, Non-Powered, Non-Penetrating
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)
  • K781446 — C RING CLINCHER (September 27, 1978)
  • K781448 — HARRINGTON HOOK CLAMP (September 27, 1978)
  • K781447 — THREADED ROD CLAMP (September 27, 1978)

FDA data resources