Alpha Mirage Top Tightening Spinal System
FDA 510(k) K023299 · Alphatec Mfg., Inc.
510(k) numberK023299
Submission
- Device name
- Alpha Mirage Top Tightening Spinal System
- Applicant
- Alphatec Mfg., Inc.
Carlsbad, CA, US - Received
- October 3, 2002
- Decision date
- December 11, 2002
- 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 |
|---|---|---|
| K033090 | Icon Polyaxial Pedicle Screw SystemKWP · Traditional | 03/26/2004SE |
| K020356 | Alpha Mirage Top Tightening Spinal SystemMNH · Traditional | 07/23/2002SE |
| K993513 | Deltaloc Anterior Cervical Plate SystemKWQ · Traditional | 04/26/2000SE |
| K993873 | Alphatec External Fixation System Compression/Distraction RodKTT · Traditional | 01/03/2000SE |
| K992350 | Pylon Intramedullaary Nail SystemHSB · Traditional | 09/22/1999SE |
| K980788 | Alphatec Wire External Fixation SystemJDW · Traditional | 05/22/1998SE |
| K964400 | Alphatec External Fixation SystemKTT · Traditional | 04/28/1997SE |
| K951846 | Mirage Spinal System for Severe SpondylolisthesisKWP · Traditional | 02/14/1996SN |
| K926417 | Alphatec 130-150 Slotted Compression Hip ScrewKTT · Traditional | 09/28/1994SE |
| K930515 | Alpha Spinal SystemKWP · Traditional | 06/29/1994SESK |
Questions and answers
When was Alpha Mirage Top Tightening Spinal System cleared by the FDA?
Alpha Mirage Top Tightening Spinal System (K023299) received a 510(k) decision of Substantially Equivalent on December 11, 2002, 69 days after the submission was received.
What is the product code of K023299?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.