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510(k) K102180

RHEAD RADIAL HEAD EXTENDED STEMS by Small Bone Innovations, Inc. — Product Code JDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2010
Date Received
August 2, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Semi-Constrained, Cemented
Device Class
Class II
Regulation Number
888.3160
Review Panel
OR
Submission Type

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  • 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)
  • K071549 — SBI RHEAD PLATING SYSTEM (August 7, 2007)

Other clearances for product code JDB

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  • K171010 — Latitude EV Total Elbow Arthroplasty (August 31, 2017)
  • K100562 — LATITUDE ELBOW PROSTHESIS (June 29, 2010)
  • K070787 — LATITUDE ELBOW PROTHESIS (August 24, 2007)
  • K070236 — SBI LATERAL RADIO CAPITELLUM (February 21, 2007)
  • K060438 — RHS (April 18, 2006)
  • K060038 — SBI RADIO-CAPITELLAR IMPLANT (March 30, 2006)
  • K050848 — TORNIER ELBOW PROSTHESIS (July 14, 2005)