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FDA 510(k)

HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)

K-Number: K870128 · 1987-05-13

ApplicantRichards Medical Co., Inc.
Decision Date1987-05-13
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE) is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1987-05-13 under 510(k) number K870128. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)?

HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE) is a medical device that received FDA 510(k) clearance on 1987-05-13. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K870128.

When did HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE) receive FDA 510(k) clearance?

HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE) received FDA 510(k) clearance on 1987-05-13, under 510(k) number K870128.

Who is the listed applicant for HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)?

The FDA 510(k) record lists Richards Medical Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)?

The FDA product code for HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE) is JDI.

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Other records listing Richards Medical Co., Inc. 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.

K896106ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTSK900628MODULAR HIP SYSTEMK896580UNI-POLAR HEADK895241INTRAMEDULLARY HIP SCREWK884824TRICON-M TOTAL KNEE SYSTEMK896204ZIRCONIA CERAMIC HEAD ADD'L SIZES

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Related Devices (Code: JDI)

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.

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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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