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510(k) K103513

LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA by Advanced Orthopaedic Solutions, Inc. — Product Code HRS

K103513 is an FDA 510(k) premarket notification submitted by Advanced Orthopaedic Solutions, Inc. for the device "LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA". The FDA issued a decision of Substantially Equivalent on October 24, 2011. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Advanced Orthopaedic Solutions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2011
Date Received
November 30, 2010
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 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 HRS

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  • K261191 — Alians Elbow S (July 8, 2026)
  • K261054 — RibPlate System (July 1, 2026)
  • K261351 — SALGINA 2.5mm Distal Radius System (June 26, 2026)
  • K260958 — I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with An (June 16, 2026)
  • K261207 — Exalta Proximal Tibia Plating System (June 12, 2026)
  • K260761 — APTUS Clavicle System 2.8 (June 5, 2026)
  • K261002 — Pectus Blu System (June 2, 2026)
  • K261038 — Xpert PFP (May 29, 2026)
  • K261145 — Avanti Distal Elbow ORIF System (May 9, 2026)

FDA data resources