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510(k) K910225

BONE PAD REMOVER by Acra Cut, Inc. — Product Code HAO

K910225 is an FDA 510(k) premarket notification submitted by Acra Cut, Inc. for the device "BONE PAD REMOVER". The FDA issued a decision of Substantially Equivalent on February 12, 1991. The device falls under product code HAO (Instrument, Surgical, Non-Powered), a Class I device regulated under 21 CFR 882.4535. Acra Cut, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1991
Date Received
January 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Non-Powered
Device Class
Class I
Regulation Number
882.4535
Review Panel
NE
Submission Type

Other clearances by Acra Cut, Inc.

  • K032970 — ACRA-CUT XPRESS 120 (December 8, 2003)
  • K944311 — ACRA-CUT (November 18, 1994)
  • K911819 — ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED (September 10, 1991)
  • K911812 — ACRA-CUT WIRE PASS DRILL (September 10, 1991)
  • K910226 — DURAL DISSECTORS (February 12, 1991)
  • K892866 — AUTOMATIC CRANIAL DRILL (PERFORATOR) (June 15, 1989)
  • K833266 — ACRA-CUT (December 29, 1983)

Other clearances for product code HAO

  • K220920 — Matreneu Percutaneous Balloon Compression Kit (September 7, 2022)
  • K940973 — MULLAN GANGLION MICROCOMPRESSION SET (September 29, 1995)
  • K951492 — RIB RESECTOR (May 18, 1995)
  • K943115 — AUTO SUTURE PITUITARY SPINAL RONGEUR (July 25, 1994)
  • K942969 — AUTO SUTURE SPINAL NERVE HOOK (July 20, 1994)
  • K942971 — AUTO SUTURE SPINAL DISSECTOR (July 20, 1994)
  • K942967 — AUTO SUTURE SPINAL CURETTE (July 20, 1994)
  • K942968 — AUTO SUTURE SPINAL OSTEOTOME (July 20, 1994)
  • K942970 — AUTO SUTURE SPINAL ELEVATOR (July 20, 1994)
  • K923723 — SILICONE BRAIN SPATULA SET (August 12, 1992)

FDA data resources