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FDA 510(k)

ISSYS LP SPINAL FIXATION SYSTEM

K-Number: K111099 · 2011-05-05

ApplicantCustom Spine, Inc.
Decision Date2011-05-05
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISSYS LP SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Custom Spine, Inc.. It received FDA 510(k) clearance on 2011-05-05 under 510(k) number K111099. 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 ISSYS LP SPINAL FIXATION SYSTEM?

ISSYS LP SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-05. The listed applicant is Custom Spine, Inc.. The 510(k) number is K111099.

When did ISSYS LP SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

ISSYS LP SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2011-05-05, under 510(k) number K111099.

Who is the listed applicant for ISSYS LP SPINAL FIXATION SYSTEM?

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

What is the FDA product code for ISSYS LP SPINAL FIXATION SYSTEM?

The FDA product code for ISSYS LP SPINAL FIXATION SYSTEM is NKB.

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Other records listing Custom 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.

K120597KOMPREDAK111726PATHWAY AVIDK092904PATHWAY IVB/VBRK091134CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATEK090566PATHWAY AVIDK080281PATHWAY

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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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