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510(k) K864421

RAYLOR(TM) PERIOSTEAL ELEVATORS by Cedar Surgical, Inc. — Product Code GEG

K864421 is an FDA 510(k) premarket notification submitted by Cedar Surgical, Inc. for the device "RAYLOR(TM) PERIOSTEAL ELEVATORS". The FDA issued a decision of Substantially Equivalent on November 26, 1986. The device falls under product code GEG (Elevator, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Cedar Surgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1986
Date Received
November 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elevator, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Cedar Surgical, Inc.

  • K873692 — RAYLOR(TM) DRILL STOP (December 17, 1987)
  • K872281 — RAYLOR FUSION FUNNEL (November 2, 1987)
  • K873690 — CEDAR(TM) PELVIC CUSHION (October 26, 1987)
  • K873691 — CEDAR(TM) RETRACTOR RING (September 28, 1987)
  • K864425 — RAYLOR(TM) DISSECTING HOOK (December 12, 1986)
  • K864426 — RAYLOR(TM) DEPTH GAUGE (November 26, 1986)
  • K864424 — RAYLOR(TM) PROTECTIVE RETRACTOR (November 26, 1986)
  • K864423 — RAYLOR(TM) OSTEOTOMES (November 24, 1986)
  • K864422 — RAYLOR(TM) MALLET (November 24, 1986)
  • K863416 — RAYLOR MINI-PROBE (September 24, 1986)

Other clearances for product code GEG

  • K891899 — ELEVATORS, VARIOUS TYPES (April 12, 1989)
  • K891894 — ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE (April 12, 1989)
  • K890365 — SEPTUM ELEVATOR (February 3, 1989)
  • K890230 — LIGATURE NEEDLES (January 27, 1989)
  • K890253 — SURGICAL ELEVATOR (January 27, 1989)
  • K872491 — 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS (July 16, 1987)
  • K870781 — ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS (March 9, 1987)
  • K870591 — ELEVATOR, COBB SPINAL (February 26, 1987)
  • K870126 — FEMUR WRENCH (February 3, 1987)
  • K834176 — H.R. JAKOBI SURG. INSTRUMENTS 40/41 (January 27, 1984)

FDA data resources