Polyaxial Hemispherical Spinal Screws
FDA 510(k) K051063 · Scient'X
510(k) numberK051063
Submission
- Device name
- Polyaxial Hemispherical Spinal Screws
- Applicant
- Scient'X
Round Rock, TX, US - Received
- April 26, 2005
- Decision date
- May 23, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
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| K071261 | Isobar Semi-Rigid Dual DampenerNQP · Traditional | 04/17/2008SE |
| K062912 | Scient'X Spinal SystemMNI · Special | 02/05/2007SE |
| K052763 | Stella Cervical PlateKWQ · Special | 11/10/2005SE |
| K052367 | Scient'X Cement RestrictorJDK · Traditional | 10/05/2005SESU |
| K050348 | Co Vertebral Body ReplacementMQP · Special | 05/27/2005SE |
| K043001 | MX Polyaxial Pedicle ScrewMNH · Special | 12/01/2004SE |
| K042964 | MX Monoaxial Pedicle ScrewMNH · Special | 11/22/2004SE |
| K042317 | Cervical PlateKWQ · Special | 09/24/2004SE |
| K040747 | Aladyn Rigid Spine PlateMNH · Special | 06/17/2004SE |
| K040454 | Biofill Bone Void FillerMQV · Traditional | 05/07/2004SE |
Questions and answers
When was Polyaxial Hemispherical Spinal Screws cleared by the FDA?
Polyaxial Hemispherical Spinal Screws (K051063) received a 510(k) decision of Substantially Equivalent on May 23, 2005, 27 days after the submission was received.
What is the product code of K051063?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.