Home / 510(k) Clearances / K023959

510(k) K023959

JEROME GLASS RING by The Jerome Group, Inc. — Product Code HAX

K023959 is an FDA 510(k) premarket notification submitted by The Jerome Group, Inc. for the device "JEROME GLASS RING". The FDA issued a decision of Substantially Equivalent on February 21, 2003. The device falls under product code HAX (Tong, Skull For Traction), a Class II device regulated under 21 CFR 882.5960. The Jerome Group, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2003
Date Received
November 27, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tong, Skull For Traction
Device Class
Class II
Regulation Number
882.5960
Review Panel
NE
Submission Type

Other clearances by The Jerome Group, Inc.

  • K040363 — CERAMIC TIPPED SKULL PIN (April 12, 2004)

Other clearances for product code HAX

  • K090733 — PMT HALO SYSTEM (July 28, 2009)
  • K071173 — RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D (May 25, 2007)
  • K051918 — RESOLVE OPEN BACK HALO RINGS (August 17, 2005)
  • K003662 — SPINE WORKS COLLAR (July 9, 2001)
  • K980689 — FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM (February 18, 1999)
  • K930021 — J TONGS (December 6, 1995)
  • K954069 — ACE CERVICAL TRACTION HALOZS, TONGS & PINS (October 12, 1995)
  • K924606 — BREMER IMAGING TONGS-MRI MODEL (September 9, 1993)
  • K915530 — NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (August 17, 1992)
  • K873693 — LEVTECH COMPOSITE TRACTION TONGS (February 5, 1988)

FDA data resources