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FDA 510(k)

APCLO PEDICLE SCREW SYSTEMS

K-Number: K112759 · 2011-10-18

ApplicantAtlas Spine, Inc.
Decision Date2011-10-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APCLO PEDICLE SCREW SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Spine, Inc.. It received FDA 510(k) clearance on 2011-10-18 under 510(k) number K112759. 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 APCLO PEDICLE SCREW SYSTEMS?

APCLO PEDICLE SCREW SYSTEMS is a medical device that received FDA 510(k) clearance on 2011-10-18. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K112759.

When did APCLO PEDICLE SCREW SYSTEMS receive FDA 510(k) clearance?

APCLO PEDICLE SCREW SYSTEMS received FDA 510(k) clearance on 2011-10-18, under 510(k) number K112759.

Who is the listed applicant for APCLO PEDICLE SCREW SYSTEMS?

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

What is the FDA product code for APCLO PEDICLE SCREW SYSTEMS?

The FDA product code for APCLO PEDICLE SCREW SYSTEMS is NKB.

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Other records listing Atlas Spine, Inc. 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.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantK252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemK251969Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemK243191Atlas Spine Lateral Expandable Interbody SystemK202302Atlas Spine Rebar (Ti) Spacer SystemK192570Atlas Spine Expandable Cervical Standalone Interbody 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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