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510(k) K964073

BME BONE DRILL BITS by Biomedical Ent., Inc. — Product Code GEY

K964073 is an FDA 510(k) premarket notification submitted by Biomedical Ent., Inc. for the device "BME BONE DRILL BITS". The FDA issued a decision of Substantially Equivalent on November 14, 1996. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. Biomedical Ent., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1996
Date Received
October 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Biomedical Ent., Inc.

  • K133844 — SPEED TRIAD (April 7, 2014)
  • K133780 — SPEED XL (March 19, 2014)
  • K131640 — SMOOTH OR THREADED METALLIC BONE FASTENER (October 16, 2013)
  • K102107 — OSSTAPLE CHILL (September 3, 2010)
  • K091951 — HAMMERLOCK (February 19, 2010)
  • K023203 — OSSTAPLE (October 17, 2002)
  • K001353 — MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPL (March 13, 2001)
  • K001354 — MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR T (March 13, 2001)
  • K001219 — MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPL (June 21, 2000)
  • K993714 — MEMOGRAPH STAPLE, WARM SYSTEM (February 25, 2000)

Other clearances for product code GEY

  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (March 28, 2002)
  • K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (November 14, 2001)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K971941 — AQUA SPRAY (August 14, 1997)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)
  • K971268 — BONE & MARROW CLLECTION SYSTEM (July 3, 1997)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K970530 — ANSPACH LUBRICATING SYSTEM II (May 5, 1997)
  • K962789 — SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM (August 14, 1996)

FDA data resources