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FDA 510(k)

CRYSTALLINE BONE SCREW ENDO-OSSEOUS

K-Number: K834364 · 1984-03-06

ApplicantC.B.S. Biotechnics, Inc.
Decision Date1984-03-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRYSTALLINE BONE SCREW ENDO-OSSEOUS is the device name listed in this FDA 510(k) record. The listed applicant is C.B.S. Biotechnics, Inc.. It received FDA 510(k) clearance on 1984-03-06 under 510(k) number K834364. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYSTALLINE BONE SCREW ENDO-OSSEOUS?

CRYSTALLINE BONE SCREW ENDO-OSSEOUS is a medical device that received FDA 510(k) clearance on 1984-03-06. The listed applicant is C.B.S. Biotechnics, Inc.. The 510(k) number is K834364.

When did CRYSTALLINE BONE SCREW ENDO-OSSEOUS receive FDA 510(k) clearance?

CRYSTALLINE BONE SCREW ENDO-OSSEOUS received FDA 510(k) clearance on 1984-03-06, under 510(k) number K834364.

Who is the listed applicant for CRYSTALLINE BONE SCREW ENDO-OSSEOUS?

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

What is the FDA product code for CRYSTALLINE BONE SCREW ENDO-OSSEOUS?

The FDA product code for CRYSTALLINE BONE SCREW ENDO-OSSEOUS is DZE.

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Other records listing C.B.S. Biotechnics, 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.

K834361JSB JET SYRINGEK834363ENDIX RADICULAR BIOCERAMIC PINK834366SURGICAL INSTRUMENTS & ACCESSORIES

Related Devices (Code: DZE)

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

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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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