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510(k) K243190

USTOMED Bone Fixation/Bone Augmentation Systems - PIN by Ustomed Instrumente Ulrich Storz GmbH & Co. KG — Product Code DZL

K243190 is an FDA 510(k) premarket notification submitted by Ustomed Instrumente Ulrich Storz GmbH & Co. KG for the device "USTOMED Bone Fixation/Bone Augmentation Systems - PIN". The FDA issued a decision of Substantially Equivalent on June 27, 2025. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2025
Date Received
September 30, 2024
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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  • K233419 — GBR System (January 3, 2025)
  • K240321 — MP Pin flat without thread (36BMP000020/MP20) (October 17, 2024)
  • K233721 — KLS Martin Drill-Free MMF Screw (September 17, 2024)
  • K231599 — Stryker MP, Mandible, HMMF and MMF AXS Screws (August 24, 2023)
  • K222367 — SAVE GBR (March 23, 2023)
  • 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)

FDA data resources