Synthes (USA) Rapid Resorbable Cranial Clamp
FDA 510(k) K041611 · Synthes (Usa)
510(k) numberK041611
Submission
- Device name
- Synthes (USA) Rapid Resorbable Cranial Clamp
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- June 15, 2004
- Decision date
- September 8, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Synthes (USA) Rapid Resorbable Cranial Clamp cleared by the FDA?
Synthes (USA) Rapid Resorbable Cranial Clamp (K041611) received a 510(k) decision of Substantially Equivalent on September 8, 2004, 85 days after the submission was received.
What is the product code of K041611?
The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.