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FDA 510(k)

ADAPTAIN SOLUBLE IMPLANT MATERIAL

K-Number: K120220 · 2012-06-06

ApplicantCeremed , Inc.
Decision Date2012-06-06
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ADAPTAIN SOLUBLE IMPLANT MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Ceremed , Inc.. It received FDA 510(k) clearance on 2012-06-06 under 510(k) number K120220. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAPTAIN SOLUBLE IMPLANT MATERIAL?

ADAPTAIN SOLUBLE IMPLANT MATERIAL is a medical device that received FDA 510(k) clearance on 2012-06-06. The listed applicant is Ceremed , Inc.. The 510(k) number is K120220.

When did ADAPTAIN SOLUBLE IMPLANT MATERIAL receive FDA 510(k) clearance?

ADAPTAIN SOLUBLE IMPLANT MATERIAL received FDA 510(k) clearance on 2012-06-06, under 510(k) number K120220.

Who is the listed applicant for ADAPTAIN SOLUBLE IMPLANT MATERIAL?

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

What is the FDA product code for ADAPTAIN SOLUBLE IMPLANT MATERIAL?

The FDA product code for ADAPTAIN SOLUBLE IMPLANT MATERIAL is KHJ.

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Other records listing Ceremed , Inc. 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.

K161446Biopor Porous Polyethylene ImplantsK160988Biopor, AOC Porous Polyethylene, CereporK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAIK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINK103047CERETENE SOLUBLE IMPLANT MATERIALK102071OSTENE CT, AOC CT, OSTEOTENE, CERETENE

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Related Devices (Code: KHJ)

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.

K260266Tympendi™ (810)Grace Medical, Inc.K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech IncorporatedK161000Biodesign Otologic Repair GraftCook Biotech IncorporatedK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.K121360BIODESIGN ENT REPAIR GRAFTCook Biotech IncorpratedK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , 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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