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FDA 510(k)

HTR POLYMER, HTR-MX

K-Number: K904111 · 1990-11-23

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1990-11-23
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HTR POLYMER, HTR-MX is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1990-11-23 under 510(k) number K904111. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HTR POLYMER, HTR-MX?

HTR POLYMER, HTR-MX is a medical device that received FDA 510(k) clearance on 1990-11-23. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K904111.

When did HTR POLYMER, HTR-MX receive FDA 510(k) clearance?

HTR POLYMER, HTR-MX received FDA 510(k) clearance on 1990-11-23, under 510(k) number K904111.

Who is the listed applicant for HTR POLYMER, HTR-MX?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HTR POLYMER, HTR-MX?

The FDA product code for HTR POLYMER, HTR-MX is KKY.

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Related Devices (Code: KKY)

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.

K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLCK161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.K160988Biopor, AOC Porous Polyethylene, CereporCeremed , Inc.K123908OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USAK111323SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTSSynthes, Inc.K103010STRYKER PATIENT SPECIFIC POLYMER IMPLANTHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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