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FDA 510(k)

BIOPLATE RESORBABLE BONE SCREW

K-Number: K012908 · 2001-11-28

ApplicantBioplate, Inc.
Decision Date2001-11-28
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOPLATE RESORBABLE BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Bioplate, Inc.. It received FDA 510(k) clearance on 2001-11-28 under 510(k) number K012908. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPLATE RESORBABLE BONE SCREW?

BIOPLATE RESORBABLE BONE SCREW is a medical device that received FDA 510(k) clearance on 2001-11-28. The listed applicant is Bioplate, Inc.. The 510(k) number is K012908.

When did BIOPLATE RESORBABLE BONE SCREW receive FDA 510(k) clearance?

BIOPLATE RESORBABLE BONE SCREW received FDA 510(k) clearance on 2001-11-28, under 510(k) number K012908.

Who is the listed applicant for BIOPLATE RESORBABLE BONE SCREW?

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

What is the FDA product code for BIOPLATE RESORBABLE BONE SCREW?

The FDA product code for BIOPLATE RESORBABLE BONE SCREW is DZL.

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Other records listing Bioplate, 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.

K082757MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEMK082175MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATIONK070901MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEMK062819BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYK051845THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEMK031028THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

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Related Devices (Code: DZL)

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.

K254286Guided Bone Regeneration SystemDentalMaster(Xiamen)Medical Technology Co., Ltd.K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)Hager& Meisinger GmbHK251569Bone ScrewOsstem Implant Co., Ltd.K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KGK233419GBR SystemProimtech Saglik Urunleri Anonim SirketiK240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH

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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