Songer(Tm) Cable System
FDA 510(k) K913735 · Danek Medical, Inc.
510(k) numberK913735
Submission
- Device name
- Songer(Tm) Cable System
- Applicant
- Danek Medical, Inc.
Memphis, TN, US - Received
- August 20, 1991
- Decision date
- November 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
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| K990603 | Modification of the Zplate-Atl Anterior Fixation SystemKWQ · Special | 03/10/1999SE |
| K982875 | Modification to Zplate-Atl Anterior Fixation SystemKWQ · Special | 01/19/1999SE |
| 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 |
Questions and answers
When was Songer(Tm) Cable System cleared by the FDA?
Songer(Tm) Cable System (K913735) received a 510(k) decision of Substantially Equivalent on November 18, 1991, 90 days after the submission was received.
What is the product code of K913735?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.