Bioabsorbable Bankart Tack
FDA 510(k) K973849 · Hogan & Hartson
510(k) numberK973849
Submission
- Device name
- Bioabsorbable Bankart Tack
- Applicant
- Hogan & Hartson
Washington, DC, US - Received
- October 8, 1997
- Decision date
- January 6, 1998
- 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 Bioabsorbable Bankart Tack cleared by the FDA?
Bioabsorbable Bankart Tack (K973849) received a 510(k) decision of Substantially Equivalent on January 6, 1998, 90 days after the submission was received.
What is the product code of K973849?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.