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FDA 510(k)

EXCELLA-M SPINAL SYSTEM

K-Number: K042143 · 2004-10-07

ApplicantInnovasis, Inc.
Decision Date2004-10-07
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXCELLA-M SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2004-10-07 under 510(k) number K042143. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCELLA-M SPINAL SYSTEM?

EXCELLA-M SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is Innovasis, Inc.. The 510(k) number is K042143.

When did EXCELLA-M SPINAL SYSTEM receive FDA 510(k) clearance?

EXCELLA-M SPINAL SYSTEM received FDA 510(k) clearance on 2004-10-07, under 510(k) number K042143.

Who is the listed applicant for EXCELLA-M SPINAL SYSTEM?

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-M SPINAL SYSTEM?

The FDA product code for EXCELLA-M SPINAL SYSTEM is KWP.

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Other records listing Innovasis, 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.

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: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

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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