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FDA 510(k)

SYNTHES 1.3 MM SELF-DRILLING SCREW

K-Number: K983485 · 1998-12-21

ApplicantSynthes (Usa)
Decision Date1998-12-21
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNTHES 1.3 MM SELF-DRILLING SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1998-12-21 under 510(k) number K983485. 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 SYNTHES 1.3 MM SELF-DRILLING SCREW?

SYNTHES 1.3 MM SELF-DRILLING SCREW is a medical device that received FDA 510(k) clearance on 1998-12-21. The listed applicant is Synthes (Usa). The 510(k) number is K983485.

When did SYNTHES 1.3 MM SELF-DRILLING SCREW receive FDA 510(k) clearance?

SYNTHES 1.3 MM SELF-DRILLING SCREW received FDA 510(k) clearance on 1998-12-21, under 510(k) number K983485.

Who is the listed applicant for SYNTHES 1.3 MM SELF-DRILLING SCREW?

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 SYNTHES 1.3 MM SELF-DRILLING SCREW?

The FDA product code for SYNTHES 1.3 MM SELF-DRILLING SCREW 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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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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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