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510(k) K842698

BRITISH SPINAL FUSION SET by Downs Surgical , Ltd. — Product Code FZX

K842698 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "BRITISH SPINAL FUSION SET". The FDA issued a decision of Substantially Equivalent on September 12, 1984. The device falls under product code FZX (Guide, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Downs Surgical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1984
Date Received
July 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Downs Surgical , Ltd.

  • K903747 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (October 31, 1990)
  • K903748 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V (October 31, 1990)
  • K903750 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E (October 31, 1990)
  • K903749 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U (October 31, 1990)
  • K900608 — SHEPPERD LUMBAR DISCECTOMY SYSTEM (October 22, 1990)
  • K900612 — SHEPPERD TREPHINE SET (GS-501-30-V) (October 22, 1990)
  • K900613 — SHEPPERD SHELTER TUBE COMPLETE & DRILL (October 22, 1990)
  • K900609 — SHEPPERD STRAIGHT AND CURVED NEEDLES (October 22, 1990)
  • K900611 — SHEPPERD DILATATION TUBE SET (GS-501-20-H) (October 22, 1990)
  • K900616 — SHEPPERD CUTTING FORCEPS (October 22, 1990)

Other clearances for product code FZX

  • K914715 — PARALLELING GUIDES (February 16, 1994)
  • K871413 — CIVCO STEPPER (July 14, 1987)
  • K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE (July 10, 1987)
  • K862564 — A.C.L. GUIDE KIT (August 18, 1986)
  • K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY (December 24, 1985)
  • K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER (July 11, 1985)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841619 — DRILL GUIDE (July 11, 1984)
  • K841297 — TECHMEDICA DRILL GUIDE (April 25, 1984)
  • K840835 — STRAITH DRAIN INSERTER (April 23, 1984)

FDA data resources