Lanx Spinal Fixation System
FDA 510(k) K071877 · Lanx, LLC
510(k) numberK071877
Submission
- Device name
- Lanx Spinal Fixation System
- Applicant
- Lanx, LLC
Philadelphia, PA, US - Received
- July 9, 2007
- Decision date
- September 17, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MNI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation SystemMNI · Traditional | Mikron Makina Sanayi Ticaret Co. , Ltd. | 10/12/2017SE |
| K160731 | LumFix Spinal Fixation SytemMNI · Traditional | CG Bio Co., Ltd. | 10/04/2016SE |
| K151458 | Double Medical Universal Spine SystemMNI · Traditional | Double Medical Technology, Inc. | 08/22/2016SE |
| K153273 | MySpine Pedicle Screw Placement Guides - LPMNI · Traditional | Medacta International S.A. | 06/29/2016SE |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemMNI · Special | Spinevision S.A. | 04/04/2016SE |
| K160320 | PremierMNI · Traditional | Shandong Weigao Orthopaedic Device Co., Ltd. | 04/01/2016SE |
| K160003 | Sniper (R) Spine SystemMNI · Traditional | Spine Wave, Inc. | 02/26/2016SE |
| K152324 | YAHUA Spinal SystemMNI · Traditional | Beijing Weigao Yahua Artificial Joint… | 02/01/2016SE |
| K143222 | FIREFLY Pedicle Screw Navigation GuideMNI · Traditional | Mighty Oak Medical, Inc. | 12/11/2015SE |
| K150684 | WASTON General Spinal SystemMNI · Traditional | Changzhou Waston Medical Appliance Co., Ltd. | 11/18/2015SE |
More from Changzhou Waston Medical Appliance Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K131547 | Lanx Fusion SystemOVD · Special | 07/12/2013SE |
| K131156 | Lanx Spinal Fixation SystemKWP · Special | 05/24/2013SE |
| K123767 | Lanx Fusion System- SAOVD · Traditional | 03/18/2013SE |
| K121316 | Lanx Spinal Fization SystemNKB · Traditional | 09/10/2012SE |
| K122145 | Lanx Spinal Fixation SystemNKB · Special | 08/17/2012SE |
| K121940 | Lanx Spinal Fixation SystemNKB · Special | 08/02/2012SE |
| K120399 | Lanx Spinal Fixation SystemNKB · Special | 03/09/2012SE |
| K113434 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)NKB · Special | 12/19/2011SE |
| K112388 | Lanx Cervical SAOVE · Traditional | 12/16/2011SE |
| K103091 | Lanx Spinal Fixation SystemKWP · Special | 04/15/2011SE |
Questions and answers
When was Lanx Spinal Fixation System cleared by the FDA?
Lanx Spinal Fixation System (K071877) received a 510(k) decision of Substantially Equivalent on September 17, 2007, 70 days after the submission was received.
What is the product code of K071877?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.