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510(k) K864422

RAYLOR(TM) MALLET by Cedar Surgical, Inc. — Product Code HWA

K864422 is an FDA 510(k) premarket notification submitted by Cedar Surgical, Inc. for the device "RAYLOR(TM) MALLET". The FDA issued a decision of Substantially Equivalent on November 24, 1986. The device falls under product code HWA (Impactor), a Class I device regulated under 21 CFR 888.4540. Cedar Surgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1986
Date Received
November 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Impactor
Device Class
Class I
Regulation Number
888.4540
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)
  • K864426 — RAYLOR(TM) DEPTH GAUGE (November 26, 1986)
  • K864424 — RAYLOR(TM) PROTECTIVE RETRACTOR (November 26, 1986)
  • K864421 — RAYLOR(TM) PERIOSTEAL ELEVATORS (November 26, 1986)
  • K864423 — RAYLOR(TM) OSTEOTOMES (November 24, 1986)
  • K863416 — RAYLOR MINI-PROBE (September 24, 1986)

Other clearances for product code HWA

  • K933527 — MODIFICATION OF ANTERIOR SEGMENT ELECTRODES (January 25, 1994)
  • K841627 — MALLET (August 27, 1984)
  • K770205 — CEMENT CHISELS (February 8, 1977)

FDA data resources