Creo Stabilization System
FDA 510(k) K124058 · Globus Medical, Inc.
510(k) numberK124058
Submission
- Device name
- Creo Stabilization System
- Applicant
- Globus Medical, Inc.
Audubon, PA, US - Received
- December 31, 2012
- Decision date
- May 13, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OSH – Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
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Questions and answers
When was Creo Stabilization System cleared by the FDA?
Creo Stabilization System (K124058) received a 510(k) decision of Substantially Equivalent on May 13, 2013, 133 days after the submission was received.
What is the product code of K124058?
The FDA product code is OSH – Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis, a Class II (moderate risk) device regulated under 21 CFR 888.3070.