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510(k) K233255

CROSSNAV Navigation Enabled Instruments by DePuy Synthes — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2024
Date Received
September 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

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  • K231922 — DEPUY SYNTHES MAXFRAME AUTOSTRUT System (July 26, 2023)
  • K221809 — DePuy Synthes 3.5mm Intrapelvic Acetabular System (September 20, 2022)
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  • K211051 — DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LC (June 2, 2021)
  • K203414 — DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Cla (December 16, 2020)
  • K201959 — DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System (September 11, 2020)

Other clearances for product code OLO

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  • K254148 — VERTICALE GPS Instruments (February 19, 2026)
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  • K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Upda (February 19, 2026)
  • K253381 — Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (February 12, 2026)
  • K252873 — Q Interbody Instruments (February 6, 2026)
  • K252058 — ROSA Knee System with UltraSound Imaging Platform (USIP) (February 6, 2026)
  • K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite (February 6, 2026)