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A-Wedge Anterior Interbody System

by Sapphire Medical Group, Inc.

510(k) K121693

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121693 Date27 Dec 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
A-Wedge Anterior Interbody System (a-Wedge Ais)
510(k) Number
FDA Product Code
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The A-Wedge Anterior Interbody System is an intervertebral fusion device with bone graft designed for lumbar spinal procedures. It is indicated for use in intervertebral body fusion procedures in skeletally mature patients diagnosed with degenerative disc disease.

This device is identified under FDA 510(k) clearance K121693 and is classified as a Class II spinal implant. It is manufactured by Sapphire Medical Group, Inc. and is categorized under the MAX product code for intervertebral fusion devices.

Other devices from Sapphire Medical Group

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the A-Wedge Anterior Interbody System?

    The A-Wedge AIS is designed for use in intervertebral body fusion procedures. It is specifically indicated for skeletally mature patients who have been diagnosed with degenerative disc disease.

  • How is the A-Wedge AIS classified for regulatory purposes?

    This device is classified as a Class II spinal implant. It is identified under FDA 510(k) clearance K121693 and is categorized under the MAX product code for intervertebral fusion devices.

  • Who is the manufacturer of the A-Wedge Anterior Interbody System?

    The A-Wedge Anterior Interbody System is manufactured by Sapphire Medical Group, Inc., located in Vero Beach, Florida.