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510(k) K143721

PRCT2 by Fx Solutions — Product Code HRS

K143721 is an FDA 510(k) premarket notification submitted by Fx Solutions for the device "PRCT2". The FDA issued a decision of Substantially Equivalent on August 27, 2015. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Fx Solutions has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2015
Date Received
December 29, 2014
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 Fx Solutions

  • K163669 — Humeris Shoulder (May 17, 2017)
  • K162455 — Humelock Reversed Shoulder (January 17, 2017)
  • K150488 — Humelock II Reversible Shoulder System (November 13, 2015)
  • K140071 — HUMELOCK II CEMENTED SHOULDER SYSTEM (July 28, 2014)
  • K130759 — HUMELOCK II CEMENTLESS SHOULDER SYSTEM (November 9, 2013)
  • K123814 — HUMELOCK II CEMENTED SHOULDER SYSTEM (August 13, 2013)
  • K111097 — HUMELOCK CEMENTED SHOULDER PROSTHESIS (November 9, 2011)

Other clearances for product code HRS

  • K262032 — TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fus (July 16, 2026)
  • 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