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510(k) K950999

KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS by Buckman Co., Inc. — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1996
Date Received
March 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM (January 16, 1997)
  • K960451 — WEBB-MORLEY SPINE SYSTEM (April 18, 1996)
  • K945756 — IMAGN(TM) 2000 SYSTEM (December 19, 1995)
  • K940003 — VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT (October 19, 1995)
  • K951117 — LIHTAN 532 LASER (October 18, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)
  • K934429 — ANTERIOR SPINE SYSTEM (October 20, 1994)

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  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)