Passmed Spinal System

FDA 510(k) K032094 · Medicrea

Substantially Equivalent

510(k) numberK032094

Submission

Device name
Passmed Spinal System
Applicant
Medicrea
Round Rock, TX, US
Received
July 7, 2003
Decision date
November 14, 2003
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

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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

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Questions and answers

When was Passmed Spinal System cleared by the FDA?

Passmed Spinal System (K032094) received a 510(k) decision of Substantially Equivalent on November 14, 2003, 130 days after the submission was received.

What is the product code of K032094?

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