Home / 510(k) Clearances / K760109

510(k) K760109

PROSTHESIS, TOTAL HIP-RASP by Orthopedic Equipment Co., Inc. — Product Code HTR

K760109 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "PROSTHESIS, TOTAL HIP-RASP". The FDA issued a decision of Substantially Equivalent on July 20, 1976. The device falls under product code HTR (Rasp), a Class I device regulated under 21 CFR 878.4800. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1976
Date Received
June 24, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rasp
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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)

Other clearances for product code HTR

  • K870329 — ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 (February 13, 1987)
  • K870349 — BIODYNAMICS FEMORAL CANAL BRUSH #1201 (February 13, 1987)
  • K870333 — BIODYNAMICS SMALL JOINT BRUSH #1203 (February 13, 1987)
  • K813093 — RICHARDS ACETABULAR BRUSH (November 20, 1981)
  • K812506 — THE ARTHROFILE (September 24, 1981)
  • K780771 — MICRO RASPS (May 16, 1978)
  • K771016 — INTERMEDULLARY BRUSH (January 12, 1978)
  • K771745 — RASPS FOR SCRAPING BONE (September 28, 1977)

FDA data resources