Spotlight Access System
FDA 510(k) K112913 · Johnson & Johnson
510(k) numberK112913
Submission
- Device name
- Spotlight Access System
- Applicant
- Johnson & Johnson
Raynham, MA, US - Received
- October 3, 2011
- Decision date
- December 16, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|
| K113273 | Spotlight Access SystemGZT · Traditional | 01/27/2012SE |
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| K110551 | Expedium Spine SystemNKB · Special | 10/26/2011SE |
| K110694 | Concorde Bullet Spinal SystemMAX · Special | 10/11/2011SE |
| K111571 | Viper SystemsNKB · Special | 07/06/2011SE |
| K110454 | Cougar LS Lateral Cage SystemMAX · Special | 05/13/2011SE |
| K103743 | Concorde Curve SystemMAX · Special | 03/17/2011SE |
| K103490 | Expedium Spine System, Moss Miami Spine SystemNKB · Traditional | 02/17/2011SE |
| K063577 | Femoral Intrafix Screw and SheathMBI · Traditional | 01/25/2007SE |
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Questions and answers
When was Spotlight Access System cleared by the FDA?
Spotlight Access System (K112913) received a 510(k) decision of Substantially Equivalent on December 16, 2011, 74 days after the submission was received.
What is the product code of K112913?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.