Robotic Graft Delivery Instruments
FDA 510(k) K230716 · Medtronic Sofamor Danek, Inc.
510(k) numberK230716
Submission
- Device name
- Robotic Graft Delivery Instruments
- Applicant
- Medtronic Sofamor Danek, Inc.
Memphis, TN, US - Received
- March 15, 2023
- Decision date
- July 18, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Other 510(k)s with product code OLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special | Remex Medical Corp. | 08/20/2026SE |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional | Suite 201, National Innovation Centre | 07/30/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | Spineart SA | 07/29/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | SurGenTec, LLC | 07/24/2026SE |
| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | THINK Surgical, Inc. | 07/24/2026SE |
| K261113 | Op.n Spine Navigation and Robotic GuidanceOLO · Traditional | Ecential Robotics | 07/22/2026SE |
| K261852 | OTS HipOLO · Special | Ortoma AB | 07/01/2026SE |
| K253921 | VERTICALE® Navigation InstrumentsOLO · Traditional | Silony Medical GmbH | 06/26/2026SE |
| K260480 | VELYS Robotic-Assisted SolutionOLO · Traditional | Depuy Ireland UC | 06/25/2026SE |
| K260369 | Dynamis Robotic Surgical SystemOLO · Traditional | LEM Surgical AG | 06/20/2026SE |
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|---|---|---|
| K251193 | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone GraftMQV · Traditional | 06/12/2025SE |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMQV · Traditional | 01/17/2025SE |
| K212428 | Centerpiece Plate Fixation SystemNQW · Traditional | 12/13/2021SE |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMAX · Traditional | 08/26/2020SE |
| K173125 | T2 STRATOSPHERE Expandable Corpectomy SystemMQP · Traditional | 12/20/2017SE |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…MAX · Traditional | 09/19/2017SE |
| K171031 | CRESCENT Spinal SystemMAX · Special | 07/06/2017SE |
| K171468 | FUSE Spinal SystemMAX · Special | 06/13/2017SE |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…NKB · Traditional | 05/11/2017SE |
| K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM)…OUR · Traditional | 08/12/2016SE |
Questions and answers
When was Robotic Graft Delivery Instruments cleared by the FDA?
Robotic Graft Delivery Instruments (K230716) received a 510(k) decision of Substantially Equivalent on July 18, 2023, 125 days after the submission was received.
What is the product code of K230716?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.