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FDA 510(k)

SPINAL PEDICLE SCREW, FIXATION, APPLIANCE

K-Number: K952298 · 1995-12-13

ApplicantJ.B.S., S.A.
Decision Date1995-12-13
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

SPINAL PEDICLE SCREW, FIXATION, APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is J.B.S., S.A.. It received FDA 510(k) clearance on 1995-12-13 under 510(k) number K952298. 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 SPINAL PEDICLE SCREW, FIXATION, APPLIANCE?

SPINAL PEDICLE SCREW, FIXATION, APPLIANCE is a medical device that received FDA 510(k) clearance on 1995-12-13. The listed applicant is J.B.S., S.A.. The 510(k) number is K952298.

When did SPINAL PEDICLE SCREW, FIXATION, APPLIANCE receive FDA 510(k) clearance?

SPINAL PEDICLE SCREW, FIXATION, APPLIANCE received FDA 510(k) clearance on 1995-12-13, under 510(k) number K952298.

Who is the listed applicant for SPINAL PEDICLE SCREW, FIXATION, APPLIANCE?

The FDA 510(k) record lists J.B.S., S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINAL PEDICLE SCREW, FIXATION, APPLIANCE?

The FDA product code for SPINAL PEDICLE SCREW, FIXATION, APPLIANCE 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 J.B.S., S.A. 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.

K962757J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMPK955864J.B. S. C1-C2 CLAMPK953881SPINE SYSTEM SACRAL PLATEK953599CLAMP ASSEMBLYK942432J.B.S. CERVICAL SPINE SYSTEMK940666JBS SMOOTH FIXATION PIN

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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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