Phantom Softhread Soft Tissue Interference Screw
FDA 510(k) K982900 · Depuy, Inc.
510(k) numberK982900
Submission
- Device name
- Phantom Softhread Soft Tissue Interference Screw
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- August 17, 1998
- Decision date
- August 31, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Phantom Softhread Soft Tissue Interference Screw cleared by the FDA?
Phantom Softhread Soft Tissue Interference Screw (K982900) received a 510(k) decision of Substantially Equivalent on August 31, 1998, 14 days after the submission was received.
What is the product code of K982900?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.