Home / 510(k) Clearances / K193214

510(k) K193214

WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws by Biomet, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2020
Date Received
November 21, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Biomet, Inc.

  • K241014 — Biomet Kirschner Wires (K-Wires) (May 22, 2024)
  • K222760 — StageOne™ Select Hip Cement Spacer Molds (December 28, 2022)
  • K221968 — StageOne™ Shoulder Cement Spacer Molds (September 15, 2022)
  • K213287 — StageOne Knee Cement Spacer Molds (September 2, 2022)
  • K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (February 7, 2022)
  • K212435 — Comprehensive Humeral Fracture Positioning Sleeves (December 10, 2021)
  • K210192 — A.L.P.S. Clavicle Plating System (February 19, 2021)
  • K193546 — Distal Centralizers (September 25, 2020)
  • K193373 — Comprehensive® Reverse Shoulder (April 15, 2020)
  • K193402 — ALLthread PEEK Suture Anchor (March 5, 2020)

Other clearances for product code MBI

  • K251750 — Trax EX Anchor (March 12, 2026)
  • K253693 — Strut Suture; No-Tie Button (March 11, 2026)
  • K260405 — FiberTape Button (March 9, 2026)
  • K253538 — TeKBrace Knotless Anchor (March 6, 2026)
  • K254306 — Aevumed FENIX Suture Anchor (March 4, 2026)
  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)
  • K253695 — LigaMend (February 27, 2026)
  • K253763 — Y-Knotless™ Flex Anchors (January 29, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
  • K253618 — QuadLock™ Fixation System (January 6, 2026)