Statak Soft Tissue Attachment Device
FDA 510(k) K962397 · Zimmer, Inc.
510(k) numberK962397
Submission
- Device name
- Statak Soft Tissue Attachment Device
- Applicant
- Zimmer, Inc.
Warsaw, IN, US - Received
- June 21, 1996
- Decision date
- August 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Statak Soft Tissue Attachment Device cleared by the FDA?
Statak Soft Tissue Attachment Device (K962397) received a 510(k) decision of Substantially Equivalent on August 27, 1996, 67 days after the submission was received.
What is the product code of K962397?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.