Home / 510(k) Clearances / K060038

510(k) K060038

SBI RADIO-CAPITELLAR IMPLANT by Small Bone Innovations, Inc. — Product Code JDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2006
Date Received
January 6, 2006
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

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)

Other clearances for product code JDB

  • K222807 — TEMA Elbow system - Line extension (October 26, 2022)
  • K193247 — LATITUDE EV™ Total Elbow Arthroplasty (August 5, 2020)
  • K182461 — LATITUDE EV Total Elbow Arthroplasty (December 27, 2018)
  • K171010 — Latitude EV Total Elbow Arthroplasty (August 31, 2017)
  • K102180 — RHEAD RADIAL HEAD EXTENDED STEMS (December 20, 2010)
  • 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)
  • K050848 — TORNIER ELBOW PROSTHESIS (July 14, 2005)