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FDA 510(k)

CALCAMEA PLATE

K-Number: K041786 · 2004-09-08

ApplicantNew Deal, S.A.
Decision Date2004-09-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CALCAMEA PLATE is the device name listed in this FDA 510(k) record. The listed applicant is New Deal, S.A.. It received FDA 510(k) clearance on 2004-09-08 under 510(k) number K041786. 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 CALCAMEA PLATE?

CALCAMEA PLATE is a medical device that received FDA 510(k) clearance on 2004-09-08. The listed applicant is New Deal, S.A.. The 510(k) number is K041786.

When did CALCAMEA PLATE receive FDA 510(k) clearance?

CALCAMEA PLATE received FDA 510(k) clearance on 2004-09-08, under 510(k) number K041786.

Who is the listed applicant for CALCAMEA PLATE?

The FDA 510(k) record lists New Deal, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALCAMEA PLATE?

The FDA product code for CALCAMEA PLATE is HRS.

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Other records listing New Deal, S.A. 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.

K063820LISFRANC PLATEK070160MODIFICATION TO TTC PLATESK070241MODIFICATION TO LAPIDUS PLATEK060474LISFRANC PLATEK061765KALIX II IMPLANTK061594LARGE UNI-CLIP STAPLE

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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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