FDA 510(k)

CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS

K-Number: K003549 · 2001-02-15

Decision Date2001-02-15

Product CodeJEY

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2001-02-15 under 510(k) number K003549. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS?

CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS is a medical device that received FDA 510(k) clearance on 2001-02-15. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K003549.

When did CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS receive FDA 510(k) clearance?

CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS received FDA 510(k) clearance on 2001-02-15, under 510(k) number K003549.

Who is the listed applicant for CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS?

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

What is the FDA product code for CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS?

The FDA product code for CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS is JEY.

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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.