Modification to Ebi OMEGA21 Spinal Fixation System
FDA 510(k) K023204 · Ebi, L.P.
510(k) numberK023204
Submission
- Device name
- Modification to Ebi OMEGA21 Spinal Fixation System
- Applicant
- Ebi, L.P.
Parsippany, NJ, US - Received
- September 25, 2002
- Decision date
- October 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | Reliance Medical Systems, LLC | 12/02/2016SE |
| K162801 | CastleLoc Spinal Fixation SystemMNH · Special | L&K BIOMED Co., Ltd. | 11/03/2016SE |
| K162143 | FixxSure® X-LinkMNH · Traditional | Innovasis, Inc. | 09/23/2016SE |
| K161151 | Spinal fixation systemMNH · Traditional | Canwell Medical Co., Ltd. | 09/21/2016SE |
| K162189 | ANAX 5.5 Spinal SystemMNH · Special | U&I Corporation | 08/30/2016SE |
| K151362 | HC Spinal SystemMNH · Traditional | Hung Chun Bio-S Co., Ltd. | 05/05/2016SE |
| K153404 | Zavation Spinal SystemMNH · Traditional | Zavation, LLC | 04/21/2016SE |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | Captiva Spine | 03/02/2016SE |
| K143013 | Spinal Inner Fixation SystemMNH · Traditional | Changzhou Dingjian Medical Appliance Co., Ltd. | 12/11/2015SE |
| K151695 | Romeo posterior osteosynthesis systemMNH · Traditional | Spineart | 09/10/2015SE |
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|---|---|---|
| K100438 | Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemNKB · Special | 06/23/2010SE |
| K100220 | Polaris Spinal SystemNKB · Special | 05/17/2010SE |
| K093880 | Peanut Growth Control Plating SystemHRS · Traditional | 04/16/2010SE |
| K092574 | Esl Spinal SystemMAX · Traditional | 02/04/2010SE |
| K093057 | Biomet Vision Footring SystemKTT · Traditional | 12/01/2009SE |
| K092336 | C-Thru Spinal SystemMQP · Traditional | 10/15/2009SE |
| K091381 | Ibex Spinal SystemMAX · Traditional | 08/07/2009SE |
| K090203 | 5.5 Helical Flange Spinal System, Polaris ComponentsNKB · Special | 07/30/2009SE |
| K090523 | Polaris Spinal SystemNKB · Traditional | 07/01/2009SE |
| K082406 | Expandable Peek-Optima ImplantMAX · Traditional | 01/14/2009SE |
Questions and answers
When was Modification to Ebi OMEGA21 Spinal Fixation System cleared by the FDA?
Modification to Ebi OMEGA21 Spinal Fixation System (K023204) received a 510(k) decision of Substantially Equivalent on October 18, 2002, 23 days after the submission was received.
What is the product code of K023204?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.