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510(k) K071541

SBI TWISTOFIX by Small Bone Innovations, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2007
Date Received
June 5, 2007
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

Other clearances by Small Bone Innovations, Inc.

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  • K102180 — RHEAD RADIAL HEAD EXTENDED STEMS (December 20, 2010)
  • K092754 — SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 (January 19, 2010)
  • K093550 — MINI RAIL EXTERNAL FIXATOR SYSTEM (January 7, 2010)
  • K073635 — SBI SR MTP TOE IMPLANT (March 19, 2008)
  • K063635 — SBI FOREFOOT SET (August 29, 2007)
  • K071656 — SBI ARTFIX (August 27, 2007)
  • K071540 — SBI TITANIUM THREADED PIN (August 8, 2007)
  • K071549 — SBI RHEAD PLATING SYSTEM (August 7, 2007)

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