FDA 510(k)

CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM

K-Number: K051293 · 2005-06-14

Decision Date2005-06-14

Product CodeJEY

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ceremed , Inc.. It received FDA 510(k) clearance on 2005-06-14 under 510(k) number K051293. 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 CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM?

CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-14. The listed applicant is Ceremed , Inc.. The 510(k) number is K051293.

When did CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM receive FDA 510(k) clearance?

CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM received FDA 510(k) clearance on 2005-06-14, under 510(k) number K051293.

Who is the listed applicant for CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM?

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

What is the FDA product code for CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM?

The FDA product code for CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM is JEY.

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Other records listing Ceremed , Inc. as applicant

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Related Devices (Code: JEY)

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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.