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510(k) K864426

RAYLOR(TM) DEPTH GAUGE by Cedar Surgical, Inc. — Product Code HTJ

K864426 is an FDA 510(k) premarket notification submitted by Cedar Surgical, Inc. for the device "RAYLOR(TM) DEPTH GAUGE". The FDA issued a decision of Substantially Equivalent on November 26, 1986. The device falls under product code HTJ (Gauge, Depth), a Class I device regulated under 21 CFR 888.4300. 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
Gauge, Depth
Device Class
Class I
Regulation Number
888.4300
Review Panel
OR
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)
  • K864424 — RAYLOR(TM) PROTECTIVE RETRACTOR (November 26, 1986)
  • K864421 — RAYLOR(TM) PERIOSTEAL ELEVATORS (November 26, 1986)
  • K864423 — RAYLOR(TM) OSTEOTOMES (November 24, 1986)
  • K864422 — RAYLOR(TM) MALLET (November 24, 1986)
  • K863415 — RAYLOR BONE IMPACTORS (September 24, 1986)

Other clearances for product code HTJ

  • K940480 — ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE (March 23, 1994)
  • K925335 — ACUFEX INTRA ARTICULAR MEASURING DEVICE (December 29, 1992)
  • K873191 — ACROMED INTERBODY DEPTH GAUGES (September 9, 1987)

FDA data resources