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510(k) K831772

GUILLOTINE BLADE by Ortho Pared Instruments, Inc. — Product Code HTZ

K831772 is an FDA 510(k) premarket notification submitted by Ortho Pared Instruments, Inc. for the device "GUILLOTINE BLADE". The FDA issued a decision of Substantially Equivalent on July 7, 1983. The device falls under product code HTZ (Instrument, Cutting, Orthopedic), a Class I device regulated under 21 CFR 878.4800. Ortho Pared Instruments, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1983
Date Received
June 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cutting, Orthopedic
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ortho Pared Instruments, Inc.

  • K820225 — MENISCUS EXTRACTOR (February 4, 1982)
  • K820226 — UNIVERSALL DRILL GUIDE (February 4, 1982)
  • K812566 — UNIVERSAL SUTURE PASSER (November 10, 1981)

Other clearances for product code HTZ

  • K933933 — CEBOPLANE (April 15, 1994)
  • K931737 — HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (January 7, 1994)
  • K870882 — 45 DEGREE SHAVER (March 23, 1987)
  • K853678 — KAMBIN SPINAL INSTRUMENT SET (September 24, 1985)
  • K850527 — ARTHROSCOPY SUCTION BIOPSY PUNCH (March 14, 1985)
  • K850423 — CONCEPT SUCTION SLEEVE (March 14, 1985)
  • K841980 — SIDE CUTTING SERRATED BLADE (August 15, 1984)
  • K842774 — CODMAN SUCTION PUNCH-PRODUCT CODES (July 27, 1984)
  • K841978 — LATERAL RELEASE KNIFE 5MM & 7MM (June 19, 1984)
  • K841973 — BANANA KNIFE SERRATED (June 19, 1984)

FDA data resources