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FDA 510(k)

SKAFFOLD CIS

K-Number: K111538 · 2011-10-25

ApplicantSkeletal Kinetics, LLC
Decision Date2011-10-25
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

SKAFFOLD CIS 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 2011-10-25 under 510(k) number K111538. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKAFFOLD CIS?

SKAFFOLD CIS is a medical device that received FDA 510(k) clearance on 2011-10-25. The listed applicant is Skeletal Kinetics, LLC. The 510(k) number is K111538.

When did SKAFFOLD CIS receive FDA 510(k) clearance?

SKAFFOLD CIS received FDA 510(k) clearance on 2011-10-25, under 510(k) number K111538.

Who is the listed applicant for SKAFFOLD CIS?

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 SKAFFOLD CIS?

The FDA product code for SKAFFOLD CIS is MTJ.

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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 FILLERK100986CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATIONK051784OSTEOVATION CMF BONE VOID FILLERK051123CALLOS IMPACT AND INJECT BONE VOID FILLER

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Related Devices (Code: MTJ)

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.

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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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