Trifix Spinal Fixation System
FDA 510(k) K001627 · Endius, Inc.
510(k) numberK001627
Submission
- Device name
- Trifix Spinal Fixation System
- Applicant
- Endius, Inc.
Plainville, MA, US - Received
- May 26, 2000
- Decision date
- June 3, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K080258 | Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemNKB · Traditional | 03/10/2008SE |
| K073510 | Endius Title 2 Poly Axial Spinal SystemNKB · Traditional | 02/11/2008SE |
| K073267 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemNKB · Traditional | 01/30/2008SE |
| K072840 | Endius Title 2 Polyaxial Spinal SystemNKB · Traditional | 12/07/2007SE |
| K070282 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemNKB · Traditional | 09/06/2007SE |
| K070367 | Endius Title 2 Polyaxial Spinal SystemNKB · Traditional | 04/12/2007SE |
| K061345 | Modification to Endius Atavi SystemHRX · Special | 06/06/2006SE |
| K060990 | Endius Title 2 Poly Axial Spinal SystemNKB · Traditional | 04/26/2006SE |
| K060683 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemKWP · Traditional | 04/18/2006SE |
| K053267 | Endius Atavi SystemHRX · Traditional | 01/13/2006SE |
Questions and answers
When was Trifix Spinal Fixation System cleared by the FDA?
Trifix Spinal Fixation System (K001627) received a 510(k) decision of Substantially Equivalent on June 3, 2000, 8 days after the submission was received.
What is the product code of K001627?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.