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510(k) K780397

ORTHOPEDIC FORCEPS by Orthopedic Equipment Co., Inc. — Product Code HTX

K780397 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "ORTHOPEDIC FORCEPS". The FDA issued a decision of Substantially Equivalent on March 22, 1978. The device falls under product code HTX (Rongeur), a Class I device regulated under 21 CFR 888.4540. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1978
Date Received
March 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur
Device Class
Class I
Regulation Number
888.4540
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)

Other clearances for product code HTX

  • K874954 — MANUAL RONGEUR (December 30, 1987)
  • K841620 — FRONT RADIUS CUTTER (September 20, 1984)
  • K841621 — BACK RADIUS CUTTER (September 20, 1984)
  • K760325 — SURGICAL INSTRUMENTS, ORTHOPEDIC (August 3, 1976)

FDA data resources