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FDA 510(k)

2.0 X 6MM SCREW

K-Number: K955140 · 1996-01-05

ApplicantBrasseler USA I, L.P.
Decision Date1996-01-05
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

2.0 X 6MM SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Brasseler USA I, L.P.. It received FDA 510(k) clearance on 1996-01-05 under 510(k) number K955140. 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 2.0 X 6MM SCREW?

2.0 X 6MM SCREW is a medical device that received FDA 510(k) clearance on 1996-01-05. The listed applicant is Brasseler USA I, L.P.. The 510(k) number is K955140.

When did 2.0 X 6MM SCREW receive FDA 510(k) clearance?

2.0 X 6MM SCREW received FDA 510(k) clearance on 1996-01-05, under 510(k) number K955140.

Who is the listed applicant for 2.0 X 6MM SCREW?

The FDA 510(k) record lists Brasseler USA I, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2.0 X 6MM SCREW?

The FDA product code for 2.0 X 6MM SCREW is DZL.

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Other records listing Brasseler USA I, L.P. 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.

K030172SMALL HIGH SPEED MOTOR DRILL SYSTEMK983223DENTAL STERLIZATION TRAY/CASSETTEK945670KIRSCHNER (K-WIRE), STEINMAN PINS

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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