A-Wedge Anterior Interbody System (A-Wedge Ais)

Q: What is the product code of K121693?

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) K121693 · Sapphire Medical Group, Inc.

Substantially Equivalent

510(k) numberK121693

Submission

Device name: A-Wedge Anterior Interbody System (A-Wedge Ais)
Applicant: Sapphire Medical Group, Inc.
Vero Beach, FL, US
Received: June 7, 2012
Decision date: December 27, 2012
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 A-Wedge Anterior Interbody System (A-Wedge Ais) cleared by the FDA?

A-Wedge Anterior Interbody System (A-Wedge Ais) (K121693) received a 510(k) decision of Substantially Equivalent on December 27, 2012, 203 days after the submission was received.

What is the product code of K121693?

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.