Zenith Pedicle System
FDA 510(k) K102636 · Apollo Spine, Inc.
510(k) numberK102636
Submission
- Device name
- Zenith Pedicle System
- Applicant
- Apollo Spine, Inc.
Stoughton, MA, US - Received
- September 13, 2010
- Decision date
- March 3, 2011
- 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 |
|---|---|---|
| K120340 | Venus Facet Screw SystemMRW · Traditional | 10/19/2012SE |
| K120143 | Eclipse Vertebral Spacer System-CervicalODP · Special | 02/16/2012SE |
| K102121 | Eclipse Vertebral Spacer System-LumbarOVD · Traditional | 01/12/2011SE |
| K101588 | Eclipse Vertebral Spacer System-CervicalOVE · Traditional | 01/07/2011SE |
| K090751 | Comet Anterior Cervical Plate SystemKWQ · Special | 10/23/2009SE |
| K082504 | Apollo Anterior Cervical Plate SystemKWQ · Traditional | 01/27/2009SE |
Questions and answers
When was Zenith Pedicle System cleared by the FDA?
Zenith Pedicle System (K102636) received a 510(k) decision of Substantially Equivalent on March 3, 2011, 171 days after the submission was received.
What is the product code of K102636?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.