Smith & Nephew MDF Modular Sleeve
FDA 510(k) K100481 · Smith & Nephew, Inc.
510(k) numberK100481
Submission
- Device name
- Smith & Nephew MDF Modular Sleeve
- Applicant
- Smith & Nephew, Inc.
Memphis, TN, US - Received
- February 18, 2010
- Decision date
- July 15, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
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| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
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Questions and answers
When was Smith & Nephew MDF Modular Sleeve cleared by the FDA?
Smith & Nephew MDF Modular Sleeve (K100481) received a 510(k) decision of Substantially Equivalent on July 15, 2010, 147 days after the submission was received.
What is the product code of K100481?
The FDA product code is MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, a Class II (moderate risk) device regulated under 21 CFR 888.3353.