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FDA 510(k)

PICASSO MIS SPINAL FIXATION SYSTEM

K-Number: K120714 · 2012-08-09

ApplicantAccel Spine
Decision Date2012-08-09
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PICASSO MIS SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Accel Spine. It received FDA 510(k) clearance on 2012-08-09 under 510(k) number K120714. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICASSO MIS SPINAL FIXATION SYSTEM?

PICASSO MIS SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-08-09. The listed applicant is Accel Spine. The 510(k) number is K120714.

When did PICASSO MIS SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

PICASSO MIS SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2012-08-09, under 510(k) number K120714.

Who is the listed applicant for PICASSO MIS SPINAL FIXATION SYSTEM?

The FDA 510(k) record lists Accel Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PICASSO MIS SPINAL FIXATION SYSTEM?

The FDA product code for PICASSO MIS SPINAL FIXATION SYSTEM is NKB.

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Other records listing Accel Spine as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131981CEZANNE II INTERBODY FUSION SYSTEMK132366SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSISK132365SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATIONK121567ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEMK121568DALI SPINAL FIXATION SYSTEMK121078VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM

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Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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