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FDA 510(k)

TRUE/FLEX INTRAMEDULLARY ROD END-CAP

K-Number: K944501 · 1994-11-28

ApplicantApplied Osteo Systems, Inc.
Decision Date1994-11-28
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRUE/FLEX INTRAMEDULLARY ROD END-CAP 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 1994-11-28 under 510(k) number K944501. 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/FLEX INTRAMEDULLARY ROD END-CAP?

TRUE/FLEX INTRAMEDULLARY ROD END-CAP is a medical device that received FDA 510(k) clearance on 1994-11-28. The listed applicant is Applied Osteo Systems, Inc.. The 510(k) number is K944501.

When did TRUE/FLEX INTRAMEDULLARY ROD END-CAP receive FDA 510(k) clearance?

TRUE/FLEX INTRAMEDULLARY ROD END-CAP received FDA 510(k) clearance on 1994-11-28, under 510(k) number K944501.

Who is the listed applicant for TRUE/FLEX INTRAMEDULLARY ROD END-CAP?

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/FLEX INTRAMEDULLARY ROD END-CAP?

The FDA product code for TRUE/FLEX INTRAMEDULLARY ROD END-CAP 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 INSERTK933995TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATIONK941048TRUE/LOK MONOLATERAL/BILATERAL FIXATORK943160INTERFERENCE SCREWK934148TRUE/FLEX CLAVICLE RODSK931578TEXAS SCOTTISH RITE EASY/LOCK FIXATOR

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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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