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510(k) K071549

SBI RHEAD PLATING SYSTEM by Small Bone Innovations, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2007
Date Received
June 6, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Small Bone Innovations, Inc.

  • K130147 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL) (May 3, 2013)
  • K112982 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) (April 2, 2012)
  • 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)
  • K071541 — SBI TWISTOFIX (September 10, 2007)
  • K063635 — SBI FOREFOOT SET (August 29, 2007)
  • K071656 — SBI ARTFIX (August 27, 2007)
  • K071540 — SBI TITANIUM THREADED PIN (August 8, 2007)

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