Paramount R Ibf Device
FDA 510(k) K103228 · Theken Spine, LLC
510(k) numberK103228
Submission
- Device name
- Paramount R Ibf Device
- Applicant
- Theken Spine, LLC
Akron, OH, US - Received
- November 2, 2010
- Decision date
- January 5, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K120829 | Stainless Steel Spinal SystemNKB · Special | 05/30/2012SE |
| K120047 | Coral Spinal SystemNKB · Special | 02/03/2012SE |
| K111675 | Vu C*Pod Intervertebral Body Fusion DeviceODP · Special | 08/02/2011SE |
| K102323 | Cervical Standalone Intervertebral Body Fusion DeviceOVE · Traditional | 12/16/2010SE |
| K101310 | Vu Apod Intervertebral Body Fusion DeviceOVD · Traditional | 09/02/2010SE |
| K100970 | Stainless Steel Spinal SystemNKB · Traditional | 08/12/2010SE |
| K091266 | Theken Coral Spinal SystemNKB · Special | 06/10/2009SE |
| K083863 | Theken Atoll Oct Spinal SystemMNI · Traditional | 03/27/2009SE |
Questions and answers
When was Paramount R Ibf Device cleared by the FDA?
Paramount R Ibf Device (K103228) received a 510(k) decision of Substantially Equivalent on January 5, 2011, 64 days after the submission was received.
What is the product code of K103228?
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.