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510(k) K210228

KLS Martin IPS Preprosthetic by KLS-Martin L.P. — Product Code ELE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2022
Date Received
January 28, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Subperiosteal
Device Class
Class II
Regulation Number
872.3645
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 ELE

  • K862926 — SURGICAL VITEX (August 29, 1986)
  • K843557 — K-APATITE 20-40 MESH K-APATITE 40-60 (November 30, 1984)
  • K801208 — HOLLOW BASKET TITANIUM DENTAL IMPLANT (May 28, 1980)