510(k) K091638
K091638 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031". The FDA issued a decision of Substantially Equivalent on Sep 14, 2009. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Spinefrontier, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 14, 2009
- Date Received
- Jun 4, 2009
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.