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FDA 510(k)

FEMROD AND FEMROD RECON INSERT

K-Number: K935383 · 1995-03-21

ApplicantApplied Osteo Systems, Inc.
Decision Date1995-03-21
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FEMROD AND FEMROD RECON INSERT 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 1995-03-21 under 510(k) number K935383. 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 FEMROD AND FEMROD RECON INSERT?

FEMROD AND FEMROD RECON INSERT is a medical device that received FDA 510(k) clearance on 1995-03-21. The listed applicant is Applied Osteo Systems, Inc.. The 510(k) number is K935383.

When did FEMROD AND FEMROD RECON INSERT receive FDA 510(k) clearance?

FEMROD AND FEMROD RECON INSERT received FDA 510(k) clearance on 1995-03-21, under 510(k) number K935383.

Who is the listed applicant for FEMROD AND FEMROD RECON INSERT?

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 FEMROD AND FEMROD RECON INSERT?

The FDA product code for FEMROD AND FEMROD RECON INSERT 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.

K933995TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATIONK944501TRUE/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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