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FDA 510(k)

CAP BONE SUBSTITUTE MATERIAL

K-Number: K032307 · 2003-10-24

ApplicantEtex Corp.
Decision Date2003-10-24
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CAP BONE SUBSTITUTE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corp.. It received FDA 510(k) clearance on 2003-10-24 under 510(k) number K032307. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAP BONE SUBSTITUTE MATERIAL?

CAP BONE SUBSTITUTE MATERIAL is a medical device that received FDA 510(k) clearance on 2003-10-24. The listed applicant is Etex Corp.. The 510(k) number is K032307.

When did CAP BONE SUBSTITUTE MATERIAL receive FDA 510(k) clearance?

CAP BONE SUBSTITUTE MATERIAL received FDA 510(k) clearance on 2003-10-24, under 510(k) number K032307.

Who is the listed applicant for CAP BONE SUBSTITUTE MATERIAL?

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

What is the FDA product code for CAP BONE SUBSTITUTE MATERIAL?

The FDA product code for CAP BONE SUBSTITUTE MATERIAL is GXP.

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Other records listing Etex Corp. 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.

K100883CARRIGENK101557GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGENK093447CARRIGENK091729ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEK091607ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEK090855EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE

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Related Devices (Code: GXP)

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.

K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.K261265Permatage XT Settable Bone PuttyOrthocon, Inc.K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.K253854MONTAGE XT Cranial CementOrthocon, Inc.K241027Permatage Settable Bone PuttyOrthocon, Inc.K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, 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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