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510(k) K130887

S4C NAVIGATION INSTRUMENTS by Aesculap Implant System, Inc. — Product Code OLO

K130887 is an FDA 510(k) premarket notification submitted by Aesculap Implant System, Inc. for the device "S4C NAVIGATION INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on August 13, 2013. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Aesculap Implant System, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2013
Date Received
March 29, 2013
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.

Other clearances by Aesculap Implant System, Inc.

  • K142707 — AIS Odontoid Fracture Fixation System (December 19, 2014)
  • K142150 — AIS MODULIFT VBR SYSTEM (October 29, 2014)
  • K133802 — AIS MODULIFT VBR SYSTEM (April 17, 2014)
  • K122783 — PLASMAFIT ACETABULAR CUP AND VITELENE INSERT (October 30, 2013)
  • K123909 — AESCULAP CESPACE XP (April 15, 2013)
  • K130291 — S4 SPINAL SYSTEM (April 11, 2013)
  • K122985 — COLUMBUS REVISION KNEE SYSTEM (October 26, 2012)
  • K112551 — S4 SPINAL SYSTEM (November 21, 2011)
  • K101281 — VEGA KNEE SYSTEM (July 30, 2010)
  • K100147 — S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM (July 23, 2010)

Other clearances for product code OLO

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

FDA data resources