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FDA 510(k)

SYNTHES IN-SITU BENDER/CUTTER

K-Number: K021458 · 2002-07-24

ApplicantSynthes (Usa)
Decision Date2002-07-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES IN-SITU BENDER/CUTTER is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2002-07-24 under 510(k) number K021458. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES IN-SITU BENDER/CUTTER?

SYNTHES IN-SITU BENDER/CUTTER is a medical device that received FDA 510(k) clearance on 2002-07-24. The listed applicant is Synthes (Usa). The 510(k) number is K021458.

When did SYNTHES IN-SITU BENDER/CUTTER receive FDA 510(k) clearance?

SYNTHES IN-SITU BENDER/CUTTER received FDA 510(k) clearance on 2002-07-24, under 510(k) number K021458.

Who is the listed applicant for SYNTHES IN-SITU BENDER/CUTTER?

The FDA 510(k) record lists Synthes (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES IN-SITU BENDER/CUTTER?

The FDA product code for SYNTHES IN-SITU BENDER/CUTTER is HRS.

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Other records listing Synthes (Usa) 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.

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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