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)

RUSH PIN

K-Number: K905341 · 1990-12-11

ApplicantO'Tec Corp.
Decision Date1990-12-11
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RUSH PIN is the device name listed in this FDA 510(k) record. The listed applicant is O'Tec Corp.. It received FDA 510(k) clearance on 1990-12-11 under 510(k) number K905341. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUSH PIN?

RUSH PIN is a medical device that received FDA 510(k) clearance on 1990-12-11. The listed applicant is O'Tec Corp.. The 510(k) number is K905341.

When did RUSH PIN receive FDA 510(k) clearance?

RUSH PIN received FDA 510(k) clearance on 1990-12-11, under 510(k) number K905341.

Who is the listed applicant for RUSH PIN?

The FDA 510(k) record lists O'Tec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUSH PIN?

The FDA product code for RUSH PIN is HTY.

Other records listing O'Tec Corp. 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.

K943293SCC22/ SCC26 SHOWER COMMODE CHAIRK910093FUTURA FEMORAL HIP STEMK905358CANCELLOUS SCREWK905355BROAD SELF-COMPRESSING PLATEK905347HAGIE PINK905357CORTICAL BONE SCREW (EUROPEAN STYLE)

View all 23 devices →

Related Devices (Code: HTY)

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.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

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.

↑