Zavation IBF
FDA 510(k) K162206 · Zavation, LLC
510(k) numberK162206
Submission
- Device name
- Zavation IBF
- Applicant
- Zavation, LLC
Flowood, MS, US - Received
- August 5, 2016
- Decision date
- April 4, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K142271 | Zavation Z-Link LumbarOVD · Traditional | 12/19/2014SE |
| K141419 | ZvplastyNDN · Traditional | 09/12/2014SE |
| K141005 | Z-Link CervicalOVE · Traditional | 08/07/2014SE |
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Questions and answers
When was Zavation IBF cleared by the FDA?
Zavation IBF (K162206) received a 510(k) decision of Substantially Equivalent on April 4, 2017, 242 days after the submission was received.
What is the product code of K162206?
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.