Roc Lumbar Plating System
FDA 510(k) K090228 · Alphatec Spine, Inc.
510(k) numberK090228
Submission
- Device name
- Roc Lumbar Plating System
- Applicant
- Alphatec Spine, Inc.
Carlsnad, CA, US - Received
- January 30, 2009
- Decision date
- April 29, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | Reliance Medical Systems, LLC | 12/02/2016SE |
| K162801 | CastleLoc Spinal Fixation SystemMNH · Special | L&K BIOMED Co., Ltd. | 11/03/2016SE |
| K162143 | FixxSure® X-LinkMNH · Traditional | Innovasis, Inc. | 09/23/2016SE |
| K161151 | Spinal fixation systemMNH · Traditional | Canwell Medical Co., Ltd. | 09/21/2016SE |
| K162189 | ANAX 5.5 Spinal SystemMNH · Special | U&I Corporation | 08/30/2016SE |
| K151362 | HC Spinal SystemMNH · Traditional | Hung Chun Bio-S Co., Ltd. | 05/05/2016SE |
| K153404 | Zavation Spinal SystemMNH · Traditional | Zavation, LLC | 04/21/2016SE |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | Captiva Spine | 03/02/2016SE |
| K143013 | Spinal Inner Fixation SystemMNH · Traditional | Changzhou Dingjian Medical Appliance Co., Ltd. | 12/11/2015SE |
| K151695 | Romeo posterior osteosynthesis systemMNH · Traditional | Spineart | 09/10/2015SE |
More from Spineart
| 510(k) | Device | Decision |
|---|---|---|
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | 07/14/2026SE |
| K253216 | IntraOp Alignment System; CONTOUR3D Bending SystemSIN · Traditional | 06/25/2026SE |
| K253615 | Invictus Bands SystemOWI · Traditional | 03/25/2026SE |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…OLO · Traditional | 02/19/2026SE |
| K252842 | SafeOp 3: Neural Informatix SystemGWF · Traditional | 01/11/2026SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | 09/03/2025SE |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ · Traditional | 08/28/2025SE |
| K251080 | IdentiTi II Cervical Interbody SystemODP · Traditional | 07/03/2025SE |
| K243461 | Calibrate Interbody Systems · Traditional | 03/04/2025SE |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…MAX · Traditional | 02/03/2025SE |
Questions and answers
When was Roc Lumbar Plating System cleared by the FDA?
Roc Lumbar Plating System (K090228) received a 510(k) decision of Substantially Equivalent on April 29, 2009, 89 days after the submission was received.
What is the product code of K090228?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.