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510(k) K130625

12MM AND 13MM TIBIAL NAILS by Advanced Orthopaedic Solutions, Inc. — Product Code HSB

K130625 is an FDA 510(k) premarket notification submitted by Advanced Orthopaedic Solutions, Inc. for the device "12MM AND 13MM TIBIAL NAILS". The FDA issued a decision of Substantially Equivalent on March 28, 2013. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Advanced Orthopaedic Solutions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2013
Date Received
March 8, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Advanced Orthopaedic Solutions, Inc.

  • K202489 — AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System (October 26, 2020)
  • K202099 — AOS Galileo™ Trochanteric Nail System (August 28, 2020)
  • K191598 — AOS ES Retrograde Femoral Nail (July 18, 2019)
  • K182466 — AOS Calcaneal Plating System (October 30, 2018)
  • K160409 — AOS Anterolateral Proximal Humeral Plate (March 15, 2016)
  • K143204 — AOS Clavicle Intramedullary Device (June 3, 2015)
  • K141912 — AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FI (October 29, 2014)
  • K141228 — AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW (July 8, 2014)
  • K133081 — TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEG (December 31, 2013)
  • K132005 — RETROGRADE FEMORAL NAIL (September 10, 2013)

Other clearances for product code HSB

  • K261481 — Pangea Femur Reconstruction System (June 29, 2026)
  • K261651 — Precice™ Max System and Precice™ Ankle Salvage System (June 18, 2026)
  • K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA0 (June 18, 2026)
  • K253155 — Fule Metallic Lockable Intramedullary Nail Systems (June 17, 2026)
  • K253046 — HERA Interlocking Intramedullary Nailing System (June 16, 2026)
  • K260146 — FITBONE® TRANSPORT AND LENGTHENING SYSTEM (May 19, 2026)
  • K253991 — Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA (May 8, 2026)
  • K261043 — AUTOBAHN™ Nailing System (April 24, 2026)
  • K252016 — Arthrex Humeral Nails (March 20, 2026)
  • K252961 — Fusion FibFix Nail (March 18, 2026)

FDA data resources