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FDA 510(k)

BREMER HALO SYSTEM TITANIUM SKULL PIN

K-Number: K993099 · 1999-12-15

ApplicantDepuyacromed
Decision Date1999-12-15
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BREMER HALO SYSTEM TITANIUM SKULL PIN is the device name listed in this FDA 510(k) record. The listed applicant is Depuyacromed. It received FDA 510(k) clearance on 1999-12-15 under 510(k) number K993099. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREMER HALO SYSTEM TITANIUM SKULL PIN?

BREMER HALO SYSTEM TITANIUM SKULL PIN is a medical device that received FDA 510(k) clearance on 1999-12-15. The listed applicant is Depuyacromed. The 510(k) number is K993099.

When did BREMER HALO SYSTEM TITANIUM SKULL PIN receive FDA 510(k) clearance?

BREMER HALO SYSTEM TITANIUM SKULL PIN received FDA 510(k) clearance on 1999-12-15, under 510(k) number K993099.

Who is the listed applicant for BREMER HALO SYSTEM TITANIUM SKULL PIN?

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

What is the FDA product code for BREMER HALO SYSTEM TITANIUM SKULL PIN?

The FDA product code for BREMER HALO SYSTEM TITANIUM SKULL PIN is JEC.

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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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