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FDA 510(k)

ANATOMIC TOE SYSTEM

K-Number: K911552 · 1991-06-28

ApplicantOrthopaedic Biosystems
Decision Date1991-06-28
Product CodeLZJ
DecisionSubstantially Equivalent

Device Summary

ANATOMIC TOE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Biosystems. It received FDA 510(k) clearance on 1991-06-28 under 510(k) number K911552. The device is classified under product code LZJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANATOMIC TOE SYSTEM?

ANATOMIC TOE SYSTEM is a medical device that received FDA 510(k) clearance on 1991-06-28. The listed applicant is Orthopaedic Biosystems. The 510(k) number is K911552.

When did ANATOMIC TOE SYSTEM receive FDA 510(k) clearance?

ANATOMIC TOE SYSTEM received FDA 510(k) clearance on 1991-06-28, under 510(k) number K911552.

Who is the listed applicant for ANATOMIC TOE SYSTEM?

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

What is the FDA product code for ANATOMIC TOE SYSTEM?

The FDA product code for ANATOMIC TOE SYSTEM is LZJ.

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 Orthopaedic Biosystems 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.

K932041XANCHOR SUTURE ATTACHMENT DEVICEK922788BIOACTION LOW PROFILE SCREW SYSTEM

Related Devices (Code: LZJ)

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.

K102549THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTYAscension Orthopedics, Inc.K072251MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEMMerete Medical GmbHK950864GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)Acu Med, Inc.K941650TOTAL TOE SYSTEM IIBiomet, Inc.K924724KINETIK GREAT TOE SYSTEMKinetikos Medical, Inc.K922211OSTEOMED GREAT TOE SYSTEMOsteomed Corp.

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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