Home / 510(k) Clearances / K111008

510(k) K111008

MICROWARE BONE PLATES AND BONE SCREW by Microware Precision Co., Ltd. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2012
Date Received
April 11, 2011
Clearance Type
Special
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 Microware Precision Co., Ltd.

  • K242814 — Tandry Q-Locking Plate System (November 14, 2024)
  • K230690 — Tandry Locking Plate System (August 17, 2023)
  • K220360 — Tandry CMF Plate System (November 10, 2022)
  • K220359 — Tandry Compression Screw System (September 20, 2022)
  • K182929 — BIO-RAY A-1 Anchor Screw System (November 6, 2019)
  • K171904 — Tandry Locking Plate System (September 18, 2018)
  • K072562 — MICROWARE BONE PLATES AND BONE SCREWS (December 4, 2008)

Other clearances for product code HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)