Short and Long Soft Tissue Attachment
FDA 510(k) K022079 · Biomet, Inc.
510(k) numberK022079
Submission
- Device name
- Short and Long Soft Tissue Attachment
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- June 26, 2002
- Decision date
- September 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3650
- Specialty
- Orthopedic
- Implant
- Yes
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| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | 02/07/2022SE |
| K212435 | Comprehensive Humeral Fracture Positioning SleevesKWS · Traditional | 12/10/2021SE |
| K210192 | A.L.P.S. Clavicle Plating SystemHRS · Special | 02/19/2021SE |
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Questions and answers
When was Short and Long Soft Tissue Attachment cleared by the FDA?
Short and Long Soft Tissue Attachment (K022079) received a 510(k) decision of Substantially Equivalent on September 24, 2002, 90 days after the submission was received.
What is the product code of K022079?
The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.