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FDA 510(k)

3I CALCIUM SULFATE BONE CEMENT

K-Number: K012047 · 2001-09-19

ApplicantImplant Innovations, Inc.
Decision Date2001-09-19
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3I CALCIUM SULFATE BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Implant Innovations, Inc.. It received FDA 510(k) clearance on 2001-09-19 under 510(k) number K012047. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3I CALCIUM SULFATE BONE CEMENT?

3I CALCIUM SULFATE BONE CEMENT is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Implant Innovations, Inc.. The 510(k) number is K012047.

When did 3I CALCIUM SULFATE BONE CEMENT receive FDA 510(k) clearance?

3I CALCIUM SULFATE BONE CEMENT received FDA 510(k) clearance on 2001-09-19, under 510(k) number K012047.

Who is the listed applicant for 3I CALCIUM SULFATE BONE CEMENT?

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

What is the FDA product code for 3I CALCIUM SULFATE BONE CEMENT?

The FDA product code for 3I CALCIUM SULFATE BONE CEMENT is LYC.

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Other records listing Implant Innovations, 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.

K062636OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTSK0633413I OSSEOTITE CERTAIN DENTAL IMPLANTSK063286OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITEK063403CONICAL ANGLED ABUTMENTK061629CERTAIN PREVAIL DENTAL IMPLANTK062432NANOTITE DENTAL IMPLANTS

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Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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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