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FDA 510(k)

CALLOS CMF BONE VOID FILLER

K-Number: K042072 · 2004-09-16

ApplicantSkeletal Kinetics, LLC
Decision Date2004-09-16
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CALLOS CMF BONE VOID FILLER is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Kinetics, LLC. It received FDA 510(k) clearance on 2004-09-16 under 510(k) number K042072. 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 CALLOS CMF BONE VOID FILLER?

CALLOS CMF BONE VOID FILLER is a medical device that received FDA 510(k) clearance on 2004-09-16. The listed applicant is Skeletal Kinetics, LLC. The 510(k) number is K042072.

When did CALLOS CMF BONE VOID FILLER receive FDA 510(k) clearance?

CALLOS CMF BONE VOID FILLER received FDA 510(k) clearance on 2004-09-16, under 510(k) number K042072.

Who is the listed applicant for CALLOS CMF BONE VOID FILLER?

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

What is the FDA product code for CALLOS CMF BONE VOID FILLER?

The FDA product code for CALLOS CMF BONE VOID FILLER is GXP.

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Other records listing Skeletal Kinetics, LLC 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.

K162864OsteoVation ImpactK120354BETA-TCP GRANULESK112383CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLERK111538SKAFFOLD CISK100986CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATIONK051784OSTEOVATION CMF BONE VOID FILLER

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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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