Nuvasive Bendini Spinal Rod Bending System
FDA 510(k) K122742 · Nuvasive, Inc.
510(k) numberK122742
Submission
- Device name
- Nuvasive Bendini Spinal Rod Bending System
- Applicant
- Nuvasive, Inc.
San Diego, CA, US - Received
- September 7, 2012
- Decision date
- December 7, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
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|---|---|---|---|
| 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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| K142205 | NuVasive X-CORE(R) Expandable VBR SystemMQP · Traditional | 02/20/2015SE |
| K141968 | Nuvasive NVM5 SystemPDQ · Traditional | 11/14/2014SE |
| K140319 | Coroent Ti-C SystemMAX · Traditional | 10/09/2014SE |
| K140162 | Ap Expandable Xlif SystemMAX · Traditional | 07/02/2014SE |
Questions and answers
When was Nuvasive Bendini Spinal Rod Bending System cleared by the FDA?
Nuvasive Bendini Spinal Rod Bending System (K122742) received a 510(k) decision of Substantially Equivalent on December 7, 2012, 91 days after the submission was received.
What is the product code of K122742?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.