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FDA 510(k)

CEMENT EXTRACTION INSTRUMENT SET

K-Number: K780135 · 1978-01-31

ApplicantOrthopedic Equipment Co., Inc.
Decision Date1978-01-31
Product CodeKDG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CEMENT EXTRACTION INSTRUMENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Equipment Co., Inc.. It received FDA 510(k) clearance on 1978-01-31 under 510(k) number K780135. The device is classified under product code KDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEMENT EXTRACTION INSTRUMENT SET?

CEMENT EXTRACTION INSTRUMENT SET is a medical device that received FDA 510(k) clearance on 1978-01-31. The listed applicant is Orthopedic Equipment Co., Inc.. The 510(k) number is K780135.

When did CEMENT EXTRACTION INSTRUMENT SET receive FDA 510(k) clearance?

CEMENT EXTRACTION INSTRUMENT SET received FDA 510(k) clearance on 1978-01-31, under 510(k) number K780135.

Who is the listed applicant for CEMENT EXTRACTION INSTRUMENT SET?

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

What is the FDA product code for CEMENT EXTRACTION INSTRUMENT SET?

The FDA product code for CEMENT EXTRACTION INSTRUMENT SET is KDG.

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Other records listing Orthopedic Equipment 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.

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Related Devices (Code: KDG)

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.

K952678STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KITAvail-Southwest DivisionK952200OMNI-JUGWaterstone Medical, Inc.K894785SURGICAL CHISEL/OSTEOTOMEFdt Precision Machine Co., Inc.K891471SIL-MED WASTE FLUID DUMP BAGSil-Med Corp.K872947POREX QUALITY PLASTIC SURGERY INSTRUMENTSPorex MedicalK872092OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5Military Engineering, Inc.

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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