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FDA 510(k)

SMF TITANIUM (TI) ALLOY BONE SCREWS

K-Number: K963546 · 1997-06-24

ApplicantSynthes (Usa)
Decision Date1997-06-24
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SMF TITANIUM (TI) ALLOY BONE SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K963546. 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 SMF TITANIUM (TI) ALLOY BONE SCREWS?

SMF TITANIUM (TI) ALLOY BONE SCREWS is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Synthes (Usa). The 510(k) number is K963546.

When did SMF TITANIUM (TI) ALLOY BONE SCREWS receive FDA 510(k) clearance?

SMF TITANIUM (TI) ALLOY BONE SCREWS received FDA 510(k) clearance on 1997-06-24, under 510(k) number K963546.

Who is the listed applicant for SMF TITANIUM (TI) ALLOY BONE SCREWS?

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

What is the FDA product code for SMF TITANIUM (TI) ALLOY BONE SCREWS?

The FDA product code for SMF TITANIUM (TI) ALLOY BONE SCREWS is DZL.

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Other records listing Synthes (Usa) 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.

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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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