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FDA 510(k)

OTIS -C PLUS

K-Number: K100604 · 2010-06-14

ApplicantSciences ET Bio Materiaux (Sbm)
Decision Date2010-06-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTIS -C PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Sciences ET Bio Materiaux (Sbm). It received FDA 510(k) clearance on 2010-06-14 under 510(k) number K100604. 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 OTIS -C PLUS?

OTIS -C PLUS is a medical device that received FDA 510(k) clearance on 2010-06-14. The listed applicant is Sciences ET Bio Materiaux (Sbm). The 510(k) number is K100604.

When did OTIS -C PLUS receive FDA 510(k) clearance?

OTIS -C PLUS received FDA 510(k) clearance on 2010-06-14, under 510(k) number K100604.

Who is the listed applicant for OTIS -C PLUS?

The FDA 510(k) record lists Sciences ET Bio Materiaux (Sbm) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTIS -C PLUS?

The FDA product code for OTIS -C PLUS is HRS.

Other records listing Sciences ET Bio Materiaux (Sbm) 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.

K021963BIOSORB RESORBABLE VOID FILLER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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