Aleutian Spacer System

Q: What is the product code of K110843?

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) K110843 · K2m, Inc.

Substantially Equivalent

510(k) numberK110843

Submission

Device name: Aleutian Spacer System
Applicant: K2m, Inc.
Leesburg, VA, US
Received: March 25, 2011
Decision date: June 22, 2011
Decision: Substantially Equivalent (SESE)
Type: Special 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 Aleutian Spacer System cleared by the FDA?

Aleutian Spacer System (K110843) received a 510(k) decision of Substantially Equivalent on June 22, 2011, 89 days after the submission was received.

What is the product code of K110843?

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.