Aesculap Resorbable Pin, Model FR735
FDA 510(k) K070178 · Aesculap Implant System, Inc.
510(k) numberK070178
Submission
- Device name
- Aesculap Resorbable Pin, Model FR735
- Applicant
- Aesculap Implant System, Inc.
Center Valley, PA, US - Received
- January 19, 2007
- Decision date
- April 30, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Aesculap Resorbable Pin, Model FR735 cleared by the FDA?
Aesculap Resorbable Pin, Model FR735 (K070178) received a 510(k) decision of Substantially Equivalent on April 30, 2007, 101 days after the submission was received.
What is the product code of K070178?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.