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FDA 510(k)

EXCELLA II SPINAL SYSTEM MODEL EC2-00

K-Number: K102248 · 2010-10-07

ApplicantInnovasis, Inc.
Decision Date2010-10-07
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXCELLA II SPINAL SYSTEM MODEL EC2-00 is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2010-10-07 under 510(k) number K102248. 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 EXCELLA II SPINAL SYSTEM MODEL EC2-00?

EXCELLA II SPINAL SYSTEM MODEL EC2-00 is a medical device that received FDA 510(k) clearance on 2010-10-07. The listed applicant is Innovasis, Inc.. The 510(k) number is K102248.

When did EXCELLA II SPINAL SYSTEM MODEL EC2-00 receive FDA 510(k) clearance?

EXCELLA II SPINAL SYSTEM MODEL EC2-00 received FDA 510(k) clearance on 2010-10-07, under 510(k) number K102248.

Who is the listed applicant for EXCELLA II SPINAL SYSTEM MODEL EC2-00?

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

What is the FDA product code for EXCELLA II SPINAL SYSTEM MODEL EC2-00?

The FDA product code for EXCELLA II SPINAL SYSTEM MODEL EC2-00 is NKB.

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Other records listing Innovasis, Inc. as applicant

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K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)K250182Innovasis Navigation InstrumentsK241276Vector™ Pedicle Screw SystemK231899HAtetracell™-C Titanium Cervical IBF SystemK223511Excella Navigation InstrumentsK223510Matrix HA Fusion Porous Cervical IBF 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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