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510(k) K872281

RAYLOR FUSION FUNNEL by Cedar Surgical, Inc. — Product Code HXR

K872281 is an FDA 510(k) premarket notification submitted by Cedar Surgical, Inc. for the device "RAYLOR FUSION FUNNEL". The FDA issued a decision of Substantially Equivalent on November 2, 1987. The device falls under product code HXR (Spatula, Orthopedic), 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 2, 1987
Date Received
June 16, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spatula, Orthopedic
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)
  • 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)
  • 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 HXR

  • K983882 — MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL (March 15, 1999)
  • K873387 — VIDEO ARTHROSCOPE, 1.7MM X 55 MM (November 25, 1987)
  • K853436 — H-H HUNTER PASSIVE TENDON IMPLANT (October 16, 1985)

FDA data resources