Home / 510(k) Clearances / K131674

510(k) K131674

PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING by Biomet Microfixation — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2013
Date Received
June 7, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Biomet Microfixation

  • K241709 — Pectus Blu Support Bar System (September 19, 2024)
  • K223199 — 2.1 x 255mm Drill, 22mm Stop (November 15, 2022)
  • K212782 — SternaLock Sternal Closure System (May 17, 2022)
  • K212608 — RibFix Blu Thoracic Fixation System (April 22, 2022)
  • K213712 — Pectus Support Bar System (March 11, 2022)
  • K213208 — Twist Drills (December 23, 2021)
  • K202969 — Biomet Microfixation OmniMax MMF System (August 5, 2021)
  • K190576 — WalterLorenz Surgical Assist Arm Scope Holder (June 5, 2019)
  • K162974 — Biomet Microfixation RibFix Blu Thoracic Fixation System (December 9, 2016)
  • K163007 — Biomet Microfixation SternaLock 360 Sternal Closure System (November 23, 2016)

Other clearances for product code JEY

  • K253373 — Southern Craniomaxillofacial (CMF) System (December 19, 2025)
  • K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsor (November 7, 2025)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (August 16, 2024)
  • K240651 — MRI Universal (July 12, 2024)
  • K233874 — tmCMF Solution (July 11, 2024)
  • K232889 — METICULY Patient-specific titanium maxillofacial mesh implant (April 30, 2024)
  • K232350 — Stryker Facial iD System (January 13, 2024)
  • K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System (September 26, 2023)
  • K230733 — Stryker Resorbable Fixation System (August 5, 2023)
  • K222650 — Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate (December 9, 2022)