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FDA 510(k)

MOLDED POLYSULFONE TRIAL PROSTHESIS

K-Number: K811205 · 1981-05-21

ApplicantShannon Group
Decision Date1981-05-21
Product CodeHWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MOLDED POLYSULFONE TRIAL PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Shannon Group. It received FDA 510(k) clearance on 1981-05-21 under 510(k) number K811205. The device is classified under product code HWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOLDED POLYSULFONE TRIAL PROSTHESIS?

MOLDED POLYSULFONE TRIAL PROSTHESIS is a medical device that received FDA 510(k) clearance on 1981-05-21. The listed applicant is Shannon Group. The 510(k) number is K811205.

When did MOLDED POLYSULFONE TRIAL PROSTHESIS receive FDA 510(k) clearance?

MOLDED POLYSULFONE TRIAL PROSTHESIS received FDA 510(k) clearance on 1981-05-21, under 510(k) number K811205.

Who is the listed applicant for MOLDED POLYSULFONE TRIAL PROSTHESIS?

The FDA 510(k) record lists Shannon Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOLDED POLYSULFONE TRIAL PROSTHESIS?

The FDA product code for MOLDED POLYSULFONE TRIAL PROSTHESIS is HWT.

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Other records listing Shannon Group 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.

K820156THEIR ELECTRO SURGICAL COUTERY PENCIL

Related Devices (Code: HWT)

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.

K974406ORTHOPLANOrtho-Graphics, Inc.K960685ORTHODOC PREOPERATIVE PLANNER MODEL 500Integrated Surgical Systems, Inc.K894228KRONNER SPHERICAL CUTTERSKronner MedicalK870843SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIAWarsaw Orthopedic, Inc.K871323ARTHROSCOPIC MENISCAL SUTURE SYSTEMOrthopedic Systems, Inc.K8303603M OSTEOTOMY GUIDE3M Company

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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