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FDA 510(k)

INTERMEDICS ORTHOPEDICS REAMERS

K-Number: K931733 · 1994-01-26

Decision Date1994-01-26
Product CodeHTP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTERMEDICS ORTHOPEDICS REAMERS is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1994-01-26 under 510(k) number K931733. The device is classified under product code HTP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERMEDICS ORTHOPEDICS REAMERS?

INTERMEDICS ORTHOPEDICS REAMERS is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Intermedics Orthopedics. The 510(k) number is K931733.

When did INTERMEDICS ORTHOPEDICS REAMERS receive FDA 510(k) clearance?

INTERMEDICS ORTHOPEDICS REAMERS received FDA 510(k) clearance on 1994-01-26, under 510(k) number K931733.

Who is the listed applicant for INTERMEDICS ORTHOPEDICS REAMERS?

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

What is the FDA product code for INTERMEDICS ORTHOPEDICS REAMERS?

The FDA product code for INTERMEDICS ORTHOPEDICS REAMERS is HTP.

Related Clinical Trials

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.

Other records listing Intermedics Orthopedics 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.

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Related Devices (Code: HTP)

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.

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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