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FDA 510(k)

J.B.S. ANTERIOR SPINE SYSTEM(R)

K-Number: K950209 · 1995-10-11

ApplicantJ.B.S. (Usa), Inc.
Decision Date1995-10-11
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

J.B.S. ANTERIOR SPINE SYSTEM(R) is the device name listed in this FDA 510(k) record. The listed applicant is J.B.S. (Usa), Inc.. It received FDA 510(k) clearance on 1995-10-11 under 510(k) number K950209. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the J.B.S. ANTERIOR SPINE SYSTEM(R)?

J.B.S. ANTERIOR SPINE SYSTEM(R) is a medical device that received FDA 510(k) clearance on 1995-10-11. The listed applicant is J.B.S. (Usa), Inc.. The 510(k) number is K950209.

When did J.B.S. ANTERIOR SPINE SYSTEM(R) receive FDA 510(k) clearance?

J.B.S. ANTERIOR SPINE SYSTEM(R) received FDA 510(k) clearance on 1995-10-11, under 510(k) number K950209.

Who is the listed applicant for J.B.S. ANTERIOR SPINE SYSTEM(R)?

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

What is the FDA product code for J.B.S. ANTERIOR SPINE SYSTEM(R)?

The FDA product code for J.B.S. ANTERIOR SPINE SYSTEM(R) is KWQ.

Related Clinical Trials

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Other records listing J.B.S. (Usa), Inc. 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.

K955710J.B.S. T.T.A SCREW

Related Devices (Code: KWQ)

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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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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