Home / 510(k) Clearances / K210731

510(k) K210731

KLS Martin Individual Patient Solutions by KLS-Martin L.P. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2022
Date Received
March 11, 2021
Clearance Type
Traditional
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 KLS-Martin L.P.

  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K250988 — KLS Martin Pure Pectus System (December 11, 2025)
  • K250865 — KLS Martin IPS Forearm System (November 14, 2025)
  • K252573 — KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosyn (November 10, 2025)
  • K233721 — KLS Martin Drill-Free MMF Screw (September 17, 2024)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (August 16, 2024)
  • K241018 — KLS Martin Orthopedic Implants - MR Conditional (July 12, 2024)
  • K230211 — CranioXpand (November 21, 2023)
  • K222624 — KLS Martin LINOS Wrist System (May 25, 2023)
  • K222397 — KLS Martin Level One Rib Fixation System (March 29, 2023)

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)