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FDA 510(k)

AMSET(TM) CANNULATED BONE SCREW

K-Number: K931538 · 1994-05-04

ApplicantAdvanced Med/Surg, Inc.
Decision Date1994-05-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

AMSET(TM) CANNULATED BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Med/Surg, Inc.. It received FDA 510(k) clearance on 1994-05-04 under 510(k) number K931538. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the AMSET(TM) CANNULATED BONE SCREW?

AMSET(TM) CANNULATED BONE SCREW is a medical device that received FDA 510(k) clearance on 1994-05-04. The listed applicant is Advanced Med/Surg, Inc.. The 510(k) number is K931538.

When did AMSET(TM) CANNULATED BONE SCREW receive FDA 510(k) clearance?

AMSET(TM) CANNULATED BONE SCREW received FDA 510(k) clearance on 1994-05-04, under 510(k) number K931538.

Who is the listed applicant for AMSET(TM) CANNULATED BONE SCREW?

The FDA 510(k) record lists Advanced Med/Surg, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMSET(TM) CANNULATED BONE SCREW?

The FDA product code for AMSET(TM) CANNULATED BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Advanced Med/Surg, 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.

K942108COHORT BONE BRUSHK921645AMSEN SPINE IMPACTOR INSTRUMENTSK921644AMSEN HOCKEY STICK CHISELK921642AMSEN DOUBLE-ENDED FORAMINAL PROBEK921643AMSEN POSTERIOR DISC EVACUATORK905023AMSET LOCKING PLATE SYSTEM

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Related Devices (Code: HWC)

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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