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FDA 510(k)

ACROMED PEDICLE SCREW

K-Number: K951116 · 1995-08-11

ApplicantAcromed Corp.
Decision Date1995-08-11
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ACROMED PEDICLE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Acromed Corp.. It received FDA 510(k) clearance on 1995-08-11 under 510(k) number K951116. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ACROMED PEDICLE SCREW?

ACROMED PEDICLE SCREW is a medical device that received FDA 510(k) clearance on 1995-08-11. The listed applicant is Acromed Corp.. The 510(k) number is K951116.

When did ACROMED PEDICLE SCREW receive FDA 510(k) clearance?

ACROMED PEDICLE SCREW received FDA 510(k) clearance on 1995-08-11, under 510(k) number K951116.

Who is the listed applicant for ACROMED PEDICLE SCREW?

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

What is the FDA product code for ACROMED PEDICLE SCREW?

The FDA product code for ACROMED PEDICLE SCREW is MNH. This falls under the ENT category.

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Other records listing Acromed Corp. as applicant

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Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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