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510(k) K201966

7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array by 7D Surgical, Inc. — Product Code OLO

K201966 is an FDA 510(k) premarket notification submitted by 7D Surgical, Inc. for the device "7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array". The FDA issued a decision of Substantially Equivalent on Sep 3, 2020. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. 7D Surgical, Inc. has 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 3, 2020
Date Received
Jul 15, 2020
Clearance Type
Special
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
510(k)

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

Other clearances by 7D Surgical, Inc.

  • K220522 — 7D Surgical System - Percutaneous Application (7D Flash Frame) (May 20, 2022)
  • K210457 — 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2… (Jun 21, 2021)
  • K210555 — 7D Surgical System - Drill Guide (Mar 23, 2021)
  • K192945 — 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application (Nov 27, 2019)
  • K192140 — 7D Surgical System (Nov 5, 2019)
  • K183276 — 7D Surgical System (Aug 7, 2019)
  • K181041 — 7D Surgical System Cranial Application (Aug 8, 2018)
  • K180352 — 7D Surgical System (May 2, 2018)
  • K162375 — Envision 3D: Image Guidance System (Dec 29, 2016)

Other clearances for product code OLO

  • K262506 — Remex Spine Surgery Navigation - Universal Instruments (Aug 20, 2026)
  • K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral… (Jul 30, 2026)
  • K261205 — SPINEART Navigation Instrument System (Jul 29, 2026)
  • K261024 — TMINI Miniature Robotic System (Jul 24, 2026)
  • K262121 — Ion-L Navigated Instruments (Jul 24, 2026)
  • K261113 — Op.n™ Spine Navigation and Robotic Guidance (Jul 22, 2026)
  • K261852 — OTS Hip (Jul 1, 2026)
  • K253921 — VERTICALE® Navigation Instruments (Jun 26, 2026)
  • K260480 — VELYS™ Robotic-Assisted Solution (Jun 25, 2026)
  • K260369 — Dynamis Robotic Surgical System (Jun 20, 2026)

FDA data resources