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FDA 510(k)

TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION

K-Number: K933995 · 1995-01-27

ApplicantApplied Osteo Systems, Inc.
Decision Date1995-01-27
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION 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 1995-01-27 under 510(k) number K933995. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION?

TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION is a medical device that received FDA 510(k) clearance on 1995-01-27. The listed applicant is Applied Osteo Systems, Inc.. The 510(k) number is K933995.

When did TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION receive FDA 510(k) clearance?

TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION received FDA 510(k) clearance on 1995-01-27, under 510(k) number K933995.

Who is the listed applicant for TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION?

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/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION?

The FDA product code for TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION is HSB.

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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 INSERTK944501TRUE/FLEX INTRAMEDULLARY ROD END-CAPK941048TRUE/LOK MONOLATERAL/BILATERAL FIXATORK943160INTERFERENCE SCREWK931578TEXAS SCOTTISH RITE EASY/LOCK FIXATORK934148TRUE/FLEX CLAVICLE RODS

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Related Devices (Code: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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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