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FDA 510(k)

SPINE SYSTEM SACRAL PLATE

K-Number: K953881 · 1996-02-21

ApplicantJ.B.S., S.A.
Decision Date1996-02-21
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

SPINE SYSTEM SACRAL PLATE 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 1996-02-21 under 510(k) number K953881. 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 SPINE SYSTEM SACRAL PLATE?

SPINE SYSTEM SACRAL PLATE is a medical device that received FDA 510(k) clearance on 1996-02-21. The listed applicant is J.B.S., S.A.. The 510(k) number is K953881.

When did SPINE SYSTEM SACRAL PLATE receive FDA 510(k) clearance?

SPINE SYSTEM SACRAL PLATE received FDA 510(k) clearance on 1996-02-21, under 510(k) number K953881.

Who is the listed applicant for SPINE SYSTEM SACRAL PLATE?

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 SPINE SYSTEM SACRAL PLATE?

The FDA product code for SPINE SYSTEM SACRAL PLATE is MNH. This falls under the ENT category.

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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 CLAMPK953599CLAMP ASSEMBLYK952298SPINAL PEDICLE SCREW, FIXATION, APPLIANCEK942432J.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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