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510(k) K873692

RAYLOR(TM) DRILL STOP by Cedar Surgical, Inc. — Product Code HBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1987
Date Received
September 8, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device Class
Class II
Regulation Number
882.4310
Review Panel
NE
Submission Type

Other clearances by Cedar Surgical, Inc.

  • 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)
  • K864421 — RAYLOR(TM) PERIOSTEAL ELEVATORS (November 26, 1986)
  • K864424 — RAYLOR(TM) PROTECTIVE RETRACTOR (November 26, 1986)
  • K864426 — RAYLOR(TM) DEPTH GAUGE (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 HBE

  • K250815 — Hubly Drill (H100) (November 6, 2025)
  • K252060 — GREEN (October 31, 2025)
  • K252662 — UniBur (September 19, 2025)
  • K251433 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070 (June 4, 2025)
  • K250380 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.0 (March 13, 2025)
  • K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision (March 11, 2025)
  • K232684 — Surgify Halo (November 29, 2023)
  • K230619 — Hubly Electric Drill (H100) (May 4, 2023)
  • K223199 — 2.1 x 255mm Drill, 22mm Stop (November 15, 2022)
  • K213072 — 2.1 x 255mm Drill, 22mm Stop (August 23, 2022)