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FDA 510(k)

TITANIUM IMPLANT DEVICES

K-Number: K820013 · 1982-03-01

ApplicantBofors Nobelpharma, Inc.
Decision Date1982-03-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TITANIUM IMPLANT DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Bofors Nobelpharma, Inc.. It received FDA 510(k) clearance on 1982-03-01 under 510(k) number K820013. 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 TITANIUM IMPLANT DEVICES?

TITANIUM IMPLANT DEVICES is a medical device that received FDA 510(k) clearance on 1982-03-01. The listed applicant is Bofors Nobelpharma, Inc.. The 510(k) number is K820013.

When did TITANIUM IMPLANT DEVICES receive FDA 510(k) clearance?

TITANIUM IMPLANT DEVICES received FDA 510(k) clearance on 1982-03-01, under 510(k) number K820013.

Who is the listed applicant for TITANIUM IMPLANT DEVICES?

The FDA 510(k) record lists Bofors Nobelpharma, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TITANIUM IMPLANT DEVICES?

The FDA product code for TITANIUM IMPLANT DEVICES is DZE.

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Other records listing Bofors Nobelpharma, Inc. as applicant

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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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