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510(k) K182466

AOS Calcaneal Plating System by Advanced Orthopaedic Solutions — Product Code HRS

K182466 is an FDA 510(k) premarket notification submitted by Advanced Orthopaedic Solutions for the device "AOS Calcaneal Plating System". The FDA issued a decision of Substantially Equivalent on October 30, 2018. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Advanced Orthopaedic Solutions has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2018
Date Received
September 10, 2018
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

  • 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)
  • 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)
  • K123569 — ANTEGRADE FEMORAL NAIL (May 24, 2013)

Other clearances for product code HRS

  • K262098 — EnHAnce PEEK Bunion System (September 18, 2026)
  • K262963 — TMC Implant Fixation System (September 15, 2026)
  • K261647 — Tempo Plating System; Ultra Compression Screw System (September 3, 2026)
  • K261830 — FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Vario (August 28, 2026)
  • K262537 — Versalock Sterile Plating System (August 19, 2026)
  • K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM (August 13, 2026)
  • K261511 — Xpert Ankle (July 28, 2026)
  • K261406 — Versalock Proximal Tibial Plating System (July 21, 2026)
  • K262032 — TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fus (July 16, 2026)
  • K261191 — Alians Elbow S (July 8, 2026)

FDA data resources