Integrity Spinal Care System

FDA 510(k) K103248 · Integra Life Sciences

Substantially Equivalent

510(k) numberK103248

Submission

Device name
Integrity Spinal Care System
Applicant
Integra Life Sciences
Las Vegas, NV, US
Received
November 3, 2010
Decision date
April 5, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
ITH – Equipment, Traction, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5900
Specialty
Physical Medicine

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Questions and answers

When was Integrity Spinal Care System cleared by the FDA?

Integrity Spinal Care System (K103248) received a 510(k) decision of Substantially Equivalent on April 5, 2011, 153 days after the submission was received.

What is the product code of K103248?

The FDA product code is ITH – Equipment, Traction, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5900.