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FDA 510(k)

J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP

K-Number: K962757 · 1996-09-25

ApplicantJ.B.S., S.A.
Decision Date1996-09-25
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP 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 1996-09-25 under 510(k) number K962757. 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 J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP?

J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP is a medical device that received FDA 510(k) clearance on 1996-09-25. The listed applicant is J.B.S., S.A.. The 510(k) number is K962757.

When did J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP receive FDA 510(k) clearance?

J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP received FDA 510(k) clearance on 1996-09-25, under 510(k) number K962757.

Who is the listed applicant for J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP?

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 J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP?

The FDA product code for J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP is MNH. This falls under the ENT category.

Related Clinical Trials

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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.

K955864J.B. S. C1-C2 CLAMPK953881SPINE SYSTEM SACRAL PLATEK953599CLAMP ASSEMBLYK952298SPINAL PEDICLE SCREW, FIXATION, APPLIANCEK942432J.B.S. CERVICAL SPINE SYSTEMK940673J.B.S. SELF-TAPPING THREADED 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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