Indus Anterior Cervical Plate System, Model IM3XXX
FDA 510(k) K073232 · Spinefrontier, Inc.
510(k) numberK073232
Submission
- Device name
- Indus Anterior Cervical Plate System, Model IM3XXX
- Applicant
- Spinefrontier, Inc.
Beverly, MA, US - Received
- November 15, 2007
- Decision date
- February 20, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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| K142504 | SpineFrontier Lumbar Interbody Fusion Device SystemMAX · Traditional | 05/13/2015SE |
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| K143377 | PedFuse Pedicle Screw SystemMNH · Special | 02/12/2015SE |
| K141333 | Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceODP · Traditional | 11/25/2014SE |
| K142026 | Spinefrontier Arena-C Ha PEEK Cervical Intervertebral Body Fusion DeviceODP · Traditional | 10/20/2014SE |
| K141337 | Arena-CODP · Traditional | 09/08/2014SE |
| K133153 | Spinefrontier Pedfuse Pedicle Screw SystemMNH · Special | 05/14/2014SE |
Questions and answers
When was Indus Anterior Cervical Plate System, Model IM3XXX cleared by the FDA?
Indus Anterior Cervical Plate System, Model IM3XXX (K073232) received a 510(k) decision of Substantially Equivalent on February 20, 2008, 97 days after the submission was received.
What is the product code of K073232?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.