Ebi Omega 21 System
FDA 510(k) K990303 · Electro-Biology, Inc.
510(k) numberK990303
Submission
- Device name
- Ebi Omega 21 System
- Applicant
- Electro-Biology, Inc.
Parsippany, NJ, US - Received
- February 1, 1999
- Decision date
- April 29, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation SystemKWP · Traditional | L&K BIOMED Co., Ltd. | 07/29/2015SE |
| K150753 | OASYS SystemKWP · Traditional | Stryker Corporation | 06/09/2015SE |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special | Precision Spine, Inc. | 06/04/2015SE |
| K142867 | Reliance Posterior Cervical-Thoracic SystemKWP · Special | Reliance Medical Systems, LLC | 04/29/2015SE |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 04/28/2015SE |
| K142253 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/23/2015SE |
| K150229 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K143249 | SOLSTICE OCT SystemKWP · Traditional | Life Spine, Inc. | 04/07/2015SE |
| K142741 | OASYS SystemKWP · Traditional | Stryker Corporation | 01/15/2015SE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special | K2m | 12/22/2014SE |
More from K2m
| 510(k) | Device | Decision |
|---|---|---|
| K992333 | Ebi Omega 21 SystemMNI · Traditional | 10/08/1999SE |
| 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 |
| 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 (K990303) received a 510(k) decision of Substantially Equivalent on April 29, 1999, 87 days after the submission was received.
What is the product code of K990303?
The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.