Modification to Synthes (USA) (Synthes) Low Profile Neuro System
FDA 510(k) K042986 · Synthes (Usa)
510(k) numberK042986
Submission
- Device name
- Modification to Synthes (USA) (Synthes) Low Profile Neuro System
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- October 29, 2004
- Decision date
- November 17, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Modification to Synthes (USA) (Synthes) Low Profile Neuro System cleared by the FDA?
Modification to Synthes (USA) (Synthes) Low Profile Neuro System (K042986) received a 510(k) decision of Substantially Equivalent on November 17, 2004, 19 days after the submission was received.
What is the product code of K042986?
The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.