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FDA 510(k)

CALLOS

K-Number: K030554 · 2003-05-20

ApplicantSkeletal Kinetics, LLC
Decision Date2003-05-20
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CALLOS 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 2003-05-20 under 510(k) number K030554. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALLOS?

CALLOS is a medical device that received FDA 510(k) clearance on 2003-05-20. The listed applicant is Skeletal Kinetics, LLC. The 510(k) number is K030554.

When did CALLOS receive FDA 510(k) clearance?

CALLOS received FDA 510(k) clearance on 2003-05-20, under 510(k) number K030554.

Who is the listed applicant for CALLOS?

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?

The FDA product code for CALLOS is MQV.

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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: MQV)

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.

K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.K260364Device 300419 StripGeistlich Pharma AGK252797JAZBI™ Resorbable Bone Void FillerSdip Innovations Pty, Ltd.K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft SubstituteStryker SpineK253524Adaptos®Fuse Bone GraftBiomendex OYK253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteProsidyan, 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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