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510(k) K233721

KLS Martin Drill-Free MMF Screw by KLS-Martin L.P. — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2024
Date Received
November 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type

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Other clearances for product code DZL

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  • K233419 — GBR System (January 3, 2025)
  • K240321 — MP Pin flat without thread (36BMP000020/MP20) (October 17, 2024)
  • K231599 — Stryker MP, Mandible, HMMF and MMF AXS Screws (August 24, 2023)
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  • K201210 — The Micro Screw System, Micro Screw System Basic (October 8, 2021)
  • K201561 — Membrane Screws and Membrane Tacks (October 5, 2020)
  • K182881 — Bone Screw, Bone Tack (August 9, 2019)