Medical Device Manufacturer · US , Moorestown , NJ

The Jerome Group, Inc.

2 submissions · 2 cleared · Since 2003

Total

Cleared

Denied

The Jerome Group, Inc. — FDA 510(k) Submissions

The Jerome Group, Inc. has submitted 2 FDA 510(k) premarket notifications since 2003, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Fixation Accessory, Tong, Skull For Traction . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

CERAMIC TIPPED SKULL PIN

K040363 · LYT Fixation Accessory · Orthopedic

Apr 2004 59d

JEROME GLASS RING

K023959 · HAX Tong, Skull For Traction · Neurology

Feb 2003 86d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

The Jerome Group, Inc.

The Jerome Group, Inc. — FDA 510(k) Submissions

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