Ebi Omega 21 System
FDA 510(k) K992333 · Electro-Biology, Inc.
510(k) numberK992333
Submission
- Device name
- Ebi Omega 21 System
- Applicant
- Electro-Biology, Inc.
Parsippany, NJ, US - Received
- July 13, 1999
- Decision date
- October 8, 1999
- 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 |
|---|---|---|
| K992367 | Ebi Xfix Dynafix System Ha Coated ScrewsHWC · Traditional | 09/23/1999SE |
| K991941 | Ebi Xfix DFS Rail SystemKTT · Traditional | 08/19/1999SE |
| K991092 | Ebi Spinelink Anterior Cervical Spinal SystemKWQ · Special | 04/29/1999SE |
| K990303 | Ebi Omega 21 SystemKWP · Traditional | 04/29/1999SE |
| K990459 | Ebi Vuecath Endoscopic SystenHRX · Traditional | 04/23/1999SE |
| K990999 | Modification of: Ebi Spinelink SystemMAI · Special | 04/14/1999SE |
| K984027 | Ebi Spinelink SystemMNI · Traditional | 01/19/1999SE |
| K982484 | Ebi Vuecath Endoscopic Spinal SystemHRX · Traditional | 10/08/1998SE |
| K982908 | Modification to Ebi Spinelink SystemKWP · Special | 08/28/1998SE |
| K981483 | Ebi DFS Joint Fixator, Model 02800KTT · Traditional | 07/08/1998SE |
Questions and answers
When was Ebi Omega 21 System cleared by the FDA?
Ebi Omega 21 System (K992333) received a 510(k) decision of Substantially Equivalent on October 8, 1999, 87 days after the submission was received.
What is the product code of K992333?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.