Expedium 4.5MM Spine System

FDA 510(k) K071495 · Depuy Spine, A Johnson & Johnson Company

Substantially Equivalent

510(k) numberK071495

Submission

Device name
Expedium 4.5MM Spine System
Applicant
Depuy Spine, A Johnson & Johnson Company
Raynham, MA, US
Received
May 31, 2007
Decision date
June 29, 2007
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NKB – Thoracolumbosacral Pedicle Screw System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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More from L&K BIOMED Co., Ltd.

510(k)DeviceDecision
K131802Expedium, Viper. Viper 2 Spine SystemOSH · Special 09/12/2013SE
K102249Expedium Spine SystemNKB · Special 12/16/2010SE
K071927Modification to Vertebroplastic Radiopaque Bone CementNDN · Special 11/21/2007SE

Questions and answers

When was Expedium 4.5MM Spine System cleared by the FDA?

Expedium 4.5MM Spine System (K071495) received a 510(k) decision of Substantially Equivalent on June 29, 2007, 29 days after the submission was received.

What is the product code of K071495?

The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.