Modification to Zplate-Atl Anterior Fixation System
FDA 510(k) K982875 · Danek Medical, Inc.
510(k) numberK982875
Submission
- Device name
- Modification to Zplate-Atl Anterior Fixation System
- Applicant
- Danek Medical, Inc.
Memphis, TN, US - Received
- August 14, 1998
- Decision date
- January 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K994122 | Bone Graft Washer, Model 9090114 - 9090118KWQ · Traditional | 02/18/2000SE |
| K993810 | CD Horizon Spinal SystemMNH · Special | 02/03/2000SE |
| K993855 | Atlantis Anterior Cervical Plate SystemKWQ · Special | 12/15/1999SE |
| K991528 | Modification to Tenor Spinal System-Rod/Bolt ConnectorMNH · Special | 05/28/1999SE |
| K990603 | Modification of the Zplate-Atl Anterior Fixation SystemKWQ · Special | 03/10/1999SE |
| K984522 | Modification of TSRH Spinal SystemMNI · Special | 01/06/1999SE |
| K982154 | Modification of Townley Pedicle Screw Plating SystemMNI · Special | 07/13/1998SE |
| K970599 | Townley Pedicle Screw Plating SystemMNI · Traditional | 03/20/1998SE |
| K943827 | Spine FixationMNH · Traditional | 02/14/1996SN |
| K943356 | Inclusive EndoscopeHRX · Traditional | 05/10/1995SE |
Questions and answers
When was Modification to Zplate-Atl Anterior Fixation System cleared by the FDA?
Modification to Zplate-Atl Anterior Fixation System (K982875) received a 510(k) decision of Substantially Equivalent on January 19, 1999, 158 days after the submission was received.
What is the product code of K982875?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.