Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OTIS-C PLUS

K-Number: K120818 · 2012-04-19

ApplicantScience For Biomaterials
Decision Date2012-04-19
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 Science For Biomaterials. It received FDA 510(k) clearance on 2012-04-19 under 510(k) number K120818. 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 2012-04-19. The listed applicant is Science For Biomaterials. The 510(k) number is K120818.

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

OTIS-C PLUS received FDA 510(k) clearance on 2012-04-19, under 510(k) number K120818.

Who is the listed applicant for OTIS-C PLUS?

The FDA 510(k) record lists Science For Biomaterials 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 Science For Biomaterials 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.

K090994LIGAFIX INTERFACE SCREWK071155MODIFICATION TO: BIOSORB RESORBABLE VOID FILLERK070507MODIFICATION TO: LIGAFIX INTERFERENCE SCREWK061022BIO 1-KIT BIOSORB FILLED CARTRIDGE

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.

↑