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FDA 510(k)

TRUE/LOK MONOLATERAL/BILATERAL FIXATOR

K-Number: K941048 · 1994-10-03

ApplicantApplied Osteo Systems, Inc.
Decision Date1994-10-03
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRUE/LOK MONOLATERAL/BILATERAL FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Applied Osteo Systems, Inc.. It received FDA 510(k) clearance on 1994-10-03 under 510(k) number K941048. The device is classified under product code LXT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUE/LOK MONOLATERAL/BILATERAL FIXATOR?

TRUE/LOK MONOLATERAL/BILATERAL FIXATOR is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Applied Osteo Systems, Inc.. The 510(k) number is K941048.

When did TRUE/LOK MONOLATERAL/BILATERAL FIXATOR receive FDA 510(k) clearance?

TRUE/LOK MONOLATERAL/BILATERAL FIXATOR received FDA 510(k) clearance on 1994-10-03, under 510(k) number K941048.

Who is the listed applicant for TRUE/LOK MONOLATERAL/BILATERAL FIXATOR?

The FDA 510(k) record lists Applied Osteo Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUE/LOK MONOLATERAL/BILATERAL FIXATOR?

The FDA product code for TRUE/LOK MONOLATERAL/BILATERAL FIXATOR is LXT.

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.

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Other records listing Applied Osteo Systems, Inc. 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.

K935383FEMROD AND FEMROD RECON INSERTK933995TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATIONK944501TRUE/FLEX INTRAMEDULLARY ROD END-CAPK943160INTERFERENCE SCREWK934148TRUE/FLEX CLAVICLE RODSK931578TEXAS SCOTTISH RITE EASY/LOCK FIXATOR

View all 15 devices →

Related Devices (Code: LXT)

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.

K230067Para-Fix External Fixation SystemNew Paradigm BiomedicalK131636POLARUS CONNECTAcumed, LLCK132704DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWBiometK112345DISTAL VOLAR RADIUS PLATING SYSTEMSMedos International SARLK090374STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(SDePuy Orthopaedics, Inc.K073135SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONSSynthes (Usa)

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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