Summit Oct Spinal System Minipolyaxial Screws
FDA 510(k) K030103 · Depuyacromed
510(k) numberK030103
Submission
- Device name
- Summit Oct Spinal System Minipolyaxial Screws
- Applicant
- Depuyacromed
Raynham, MA, US - Received
- January 13, 2003
- Decision date
- February 5, 2003
- 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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| 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 |
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| K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsMNH · Special | 02/26/2003SE |
| K030249 | Surgical Titanium Mesh SystemMQP · Special | 02/14/2003SE |
| K023835 | Devex Mesh SystemMQP · Special | 01/29/2003SE |
| K024348 | Monarch Spine SystemMNH · Special | 01/28/2003SE |
| K023804 | Moss Miami Spinal System Pin NutKWP · Special | 01/23/2003SE |
| K021039 | Bowti Anterior Buttress Staple SystemKWQ · Traditional | 12/11/2002SE |
| K023438 | Modification to Monarch Spine SystemMNH · Special | 11/13/2002SE |
Questions and answers
When was Summit Oct Spinal System Minipolyaxial Screws cleared by the FDA?
Summit Oct Spinal System Minipolyaxial Screws (K030103) received a 510(k) decision of Substantially Equivalent on February 5, 2003, 23 days after the submission was received.
What is the product code of K030103?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.