Spine Frontier Indus Acp System
FDA 510(k) K121060 · Spinefrontier, Inc.
510(k) numberK121060
Submission
- Device name
- Spine Frontier Indus Acp System
- Applicant
- Spinefrontier, Inc.
Beverly, MA, US - Received
- April 6, 2012
- Decision date
- July 3, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K151198 | A-CIFT SoloFuseOVE · Special | 07/17/2015SE |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device SystemMAX · Traditional | 05/13/2015SE |
| K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemOUR · Traditional | 04/24/2015SE |
| 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 Spine Frontier Indus Acp System cleared by the FDA?
Spine Frontier Indus Acp System (K121060) received a 510(k) decision of Substantially Equivalent on July 3, 2012, 88 days after the submission was received.
What is the product code of K121060?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.