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FDA 510(k)

TRUE/FLEX CLAVICLE RODS

K-Number: K934148 · 1994-02-22

ApplicantApplied Osteo Systems, Inc.
Decision Date1994-02-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRUE/FLEX CLAVICLE RODS 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 1994-02-22 under 510(k) number K934148. 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 CLAVICLE RODS?

TRUE/FLEX CLAVICLE RODS is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Applied Osteo Systems, Inc.. The 510(k) number is K934148.

When did TRUE/FLEX CLAVICLE RODS receive FDA 510(k) clearance?

TRUE/FLEX CLAVICLE RODS received FDA 510(k) clearance on 1994-02-22, under 510(k) number K934148.

Who is the listed applicant for TRUE/FLEX CLAVICLE RODS?

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 CLAVICLE RODS?

The FDA product code for TRUE/FLEX CLAVICLE RODS 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 INSTRUMENTATIONK944501TRUE/FLEX INTRAMEDULLARY ROD END-CAPK941048TRUE/LOK MONOLATERAL/BILATERAL FIXATORK943160INTERFERENCE SCREWK931578TEXAS 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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