Anatomica Posterior Cervical Fixation System

FDA 510(k) K061943 · Anatomica AB

Substantially Equivalent

510(k) numberK061943

Submission

Device name
Anatomica Posterior Cervical Fixation System
Applicant
Anatomica AB
Washington, DC, US
Received
July 10, 2006
Decision date
May 25, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWP – Appliance, Fixation, Spinal Interlaminal
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3050
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KWP

510(k)DeviceApplicantDecision
K143278LnK Posterior Cervical Fixation SystemKWP · Traditional L&K BIOMED Co., Ltd.07/29/2015SE
K150753OASYS SystemKWP · Traditional Stryker Corporation06/09/2015SE
K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special Precision Spine, Inc.06/04/2015SE
K142867Reliance Posterior Cervical-Thoracic SystemKWP · Special Reliance Medical Systems, LLC04/29/2015SE
K150254Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional Pioneer Surgical Technology, Inc. (Dba Rti…04/28/2015SE
K142253SOLSTICE OCT SystemKWP · Traditional Life Spine, Inc.04/23/2015SE
K150229SOLSTICE OCT SystemKWP · Traditional Life Spine, Inc.04/07/2015SE
K143249SOLSTICE OCT SystemKWP · Traditional Life Spine, Inc.04/07/2015SE
K142741OASYS SystemKWP · Traditional Stryker Corporation01/15/2015SE
K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special K2m12/22/2014SE

Questions and answers

When was Anatomica Posterior Cervical Fixation System cleared by the FDA?

Anatomica Posterior Cervical Fixation System (K061943) received a 510(k) decision of Substantially Equivalent on May 25, 2007, 319 days after the submission was received.

What is the product code of K061943?

The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.