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FDA 510(k)

VARI-ANGLE HIP SCREW (VHS) SYSTEM

K-Number: K964880 · 1997-10-16

ApplicantWalter Abendschein, M.D.
Decision Date1997-10-16
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VARI-ANGLE HIP SCREW (VHS) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Walter Abendschein, M.D.. It received FDA 510(k) clearance on 1997-10-16 under 510(k) number K964880. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARI-ANGLE HIP SCREW (VHS) SYSTEM?

VARI-ANGLE HIP SCREW (VHS) SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-16. The listed applicant is Walter Abendschein, M.D.. The 510(k) number is K964880.

When did VARI-ANGLE HIP SCREW (VHS) SYSTEM receive FDA 510(k) clearance?

VARI-ANGLE HIP SCREW (VHS) SYSTEM received FDA 510(k) clearance on 1997-10-16, under 510(k) number K964880.

Who is the listed applicant for VARI-ANGLE HIP SCREW (VHS) SYSTEM?

The FDA 510(k) record lists Walter Abendschein, M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARI-ANGLE HIP SCREW (VHS) SYSTEM?

The FDA product code for VARI-ANGLE HIP SCREW (VHS) SYSTEM is KTT.

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 Walter Abendschein, M.D. 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.

K011603VHS PEDIATRIC HIP SCREW SYSTEMK002184COD COMPRESSION OSTEOTOMY DEVICEK000827UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTEDK991806VHS SUPRACONDYLAR PLATE SYSTEM

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253202Hoffmann LRF SystemStryker GmbHK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.

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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