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FDA 510(k)

CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER

K-Number: K990290 · 1999-11-18

ApplicantBiomet, Inc.
Decision Date1999-11-18
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1999-11-18 under 510(k) number K990290. 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 CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER?

CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER is a medical device that received FDA 510(k) clearance on 1999-11-18. The listed applicant is Biomet, Inc.. The 510(k) number is K990290.

When did CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER receive FDA 510(k) clearance?

CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER received FDA 510(k) clearance on 1999-11-18, under 510(k) number K990290.

Who is the listed applicant for CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER?

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

What is the FDA product code for CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER?

The FDA product code for CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER is GXP.

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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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