Battalion Universal Spacer System

Q: What is the product code of K143740?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K143740 · Alphatec Spine, Inc.

Substantially Equivalent

510(k) numberK143740

Submission

Device name: Battalion Universal Spacer System
Applicant: Alphatec Spine, Inc.
Carlsnad, CA, US
Received: December 30, 2014
Decision date: May 22, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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Questions and answers

When was Battalion Universal Spacer System cleared by the FDA?

Battalion Universal Spacer System (K143740) received a 510(k) decision of Substantially Equivalent on May 22, 2015, 143 days after the submission was received.

What is the product code of K143740?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.