Synthes (USA) 2ND Generation Pelvic C-Clamp
FDA 510(k) K071476 · Synthes (Usa)
510(k) numberK071476
Submission
- Device name
- Synthes (USA) 2ND Generation Pelvic C-Clamp
- Applicant
- Synthes (Usa)
West Chester, PA, US - Received
- May 29, 2007
- Decision date
- August 24, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JEC – Component, Traction, Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Synthes (USA) 2ND Generation Pelvic C-Clamp cleared by the FDA?
Synthes (USA) 2ND Generation Pelvic C-Clamp (K071476) received a 510(k) decision of Substantially Equivalent on August 24, 2007, 87 days after the submission was received.
What is the product code of K071476?
The FDA product code is JEC – Component, Traction, Invasive, a Class II (moderate risk) device regulated under 21 CFR 888.3040.