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510(k) K992396

BIORCI SCREW by Smith & Nephew Endoscopy, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2000
Date Received
July 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K083635 — SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW (January 30, 2009)
  • K083226 — SMITH & NEPHEW PEEK INTERFERENCE SCREW (January 30, 2009)
  • K082095 — ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE (October 21, 2008)
  • K050580 — SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS (April 20, 2005)
  • K991500 — SMITH & NEPHEW SUTURE LOK (July 14, 1999)
  • K972599 — ACUFEX SCREW CANNULA (September 19, 1997)
  • K971939 — SMITH & NEPHEW SUTURE COLLET (August 6, 1997)

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