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510(k) K012738

SYMPHONY GRAFT DELIVERY SYSTEM (GDS) by Depuyacromed — Product Code GEY

K012738 is an FDA 510(k) premarket notification submitted by Depuyacromed for the device "SYMPHONY GRAFT DELIVERY SYSTEM (GDS)". The FDA issued a decision of Substantially Equivalent on November 14, 2001. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. Depuyacromed has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2001
Date Received
August 16, 2001
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 Depuyacromed

  • K040197 — EAGLE ANTERIOR CERVIAL PLATE SYSTEM (April 2, 2004)
  • K031635 — DEPUY ACROMED VBR SYSTEM (June 23, 2003)
  • K030833 — DEPUY ACROMED VBR SYSTEM (April 10, 2003)
  • K030383 — MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS (February 26, 2003)
  • K030249 — SURGICAL TITANIUM MESH SYSTEM (February 14, 2003)
  • K030103 — SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS (February 5, 2003)
  • K023835 — DEVEX MESH SYSTEM (January 29, 2003)
  • K024348 — MONARCH SPINE SYSTEM (January 28, 2003)
  • K023804 — MOSS MIAMI SPINAL SYSTEM PIN NUT (January 23, 2003)
  • K021039 — BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM (December 11, 2002)

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)
  • 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)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)
  • K962789 — SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM (August 14, 1996)

FDA data resources