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FDA 510(k)

CERAMIC TIPPED SKULL PIN

K-Number: K040363 · 2004-04-12

ApplicantThe Jerome Group, Inc.
Decision Date2004-04-12
Product CodeLYT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CERAMIC TIPPED SKULL PIN is the device name listed in this FDA 510(k) record. The listed applicant is The Jerome Group, Inc.. It received FDA 510(k) clearance on 2004-04-12 under 510(k) number K040363. The device is classified under product code LYT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAMIC TIPPED SKULL PIN?

CERAMIC TIPPED SKULL PIN is a medical device that received FDA 510(k) clearance on 2004-04-12. The listed applicant is The Jerome Group, Inc.. The 510(k) number is K040363.

When did CERAMIC TIPPED SKULL PIN receive FDA 510(k) clearance?

CERAMIC TIPPED SKULL PIN received FDA 510(k) clearance on 2004-04-12, under 510(k) number K040363.

Who is the listed applicant for CERAMIC TIPPED SKULL PIN?

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

What is the FDA product code for CERAMIC TIPPED SKULL PIN?

The FDA product code for CERAMIC TIPPED SKULL PIN is LYT.

Related Clinical Trials

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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Other records listing The Jerome Group, 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.

K023959JEROME GLASS RING

Related Devices (Code: LYT)

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.

K983685BONE BANDChapel and Assoc.K980594OSTEONICS FX-CABLELOK GRIP COMPONENTSOsteonics Corp.K914812K-CAP-E, STERILEWestcon Orthopedics, Inc.K912762K-CAP-I, STERILEWestcon Orthopedics, Inc.K902053K-CAP-I ORTHOPEDIC FIXATION WIRE CAPWestcon Orthopedics, Inc.K902676MICROGUARD, ORTHOPEDIC PIN PROTECTORSMicro-Aire Surgical Instruments, Inc.

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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