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FDA 510(k)

LOWTOP PEDICLE SCREW SYSTEM

K-Number: K070933 · 2007-06-13

ApplicantSanacor
Decision Date2007-06-13
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOWTOP PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sanacor. It received FDA 510(k) clearance on 2007-06-13 under 510(k) number K070933. 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.

Frequently Asked Questions

What is the LOWTOP PEDICLE SCREW SYSTEM?

LOWTOP PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-13. The listed applicant is Sanacor. The 510(k) number is K070933.

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

LOWTOP PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2007-06-13, under 510(k) number K070933.

Who is the listed applicant for LOWTOP PEDICLE SCREW SYSTEM?

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

What is the FDA product code for LOWTOP PEDICLE SCREW SYSTEM?

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

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.

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Other records listing Sanacor 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.

K090477ALPINE PEDICLE SCREW SYSTEMK073500ACTIVE ANTERIOR CERVICAL PLATE SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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