Avs Anterior Large PEEK Spacers

Q: What is the product code of K090166?

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) K090166 · Stryker Corp.

Substantially Equivalent

510(k) numberK090166

Submission

Device name: Avs Anterior Large PEEK Spacers
Applicant: Stryker Corp.
Allendale, NJ, US
Received: January 22, 2009
Decision date: April 22, 2009
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 Avs Anterior Large PEEK Spacers cleared by the FDA?

Avs Anterior Large PEEK Spacers (K090166) received a 510(k) decision of Substantially Equivalent on April 22, 2009, 90 days after the submission was received.

What is the product code of K090166?

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.