Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR

K-Number: K981362 · 1998-06-29

ApplicantSynthes (Usa)
Decision Date1998-06-29
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K981362. 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 (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR?

SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Synthes (Usa). The 510(k) number is K981362.

When did SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR receive FDA 510(k) clearance?

SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR received FDA 510(k) clearance on 1998-06-29, under 510(k) number K981362.

Who is the listed applicant for SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR?

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 (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR?

The FDA product code for SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR is DZL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 409 devices →

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.

↑