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FDA 510(k)

MODIFICATION TO ALTIUS OCT SYSTEM

K-Number: K043229 · 2004-12-21

ApplicantInterpore Cross Intl.
Decision Date2004-12-21
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ALTIUS OCT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Interpore Cross Intl.. It received FDA 510(k) clearance on 2004-12-21 under 510(k) number K043229. 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 MODIFICATION TO ALTIUS OCT SYSTEM?

MODIFICATION TO ALTIUS OCT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-21. The listed applicant is Interpore Cross Intl.. The 510(k) number is K043229.

When did MODIFICATION TO ALTIUS OCT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO ALTIUS OCT SYSTEM received FDA 510(k) clearance on 2004-12-21, under 510(k) number K043229.

Who is the listed applicant for MODIFICATION TO ALTIUS OCT SYSTEM?

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

What is the FDA product code for MODIFICATION TO ALTIUS OCT SYSTEM?

The FDA product code for MODIFICATION TO ALTIUS OCT SYSTEM is KWP.

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Other records listing Interpore Cross Intl. 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.

K050861PEEK CASK031399INTERGRO DBMK041407TITANIUM MESH IMPLANTK042798C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEMK040928EXPANDABLE PEEK VBR IMPLANTK041794C-TEK C-THRU ANTERIOR CERVICAL PLATE 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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