TANDEM Hip System
FDA 510(k) K231448 · Smith & Nephew, Inc.
510(k) numberK231448
Submission
- Device name
- TANDEM Hip System
- Applicant
- Smith & Nephew, Inc.
Memphis, TN, US - Received
- May 18, 2023
- Decision date
- July 19, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZY – Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LZY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111145 | Endo HeadLZY · Traditional | Medacta International | 08/16/2011SE |
| K974442 | Pre-Powdered Nitrile Examination GlovesLZY · Traditional | P.T. Latexindo Tobaperkasa | 01/05/1998SE |
| K915528 | BHR Bipolar Femoral Head ComponentLZY · Traditional | Implantology Corp. | 06/29/1993SE |
| K915548 | Ionguard Titanium Modular HeadsLZY · Traditional | Biomet, Inc. | 03/10/1992SE |
| K903084 | Modular Cathcart Fracture SystemLZY · Traditional | Depuy, Inc. | 10/03/1990SE |
| K896580 | Uni-Polar HeadLZY · Traditional | Richards Medical Co., Inc. | 02/15/1990SE |
| K892059 | Femoral Heads/Modular & Fixed W/ Titan Nitride SurLZY · Traditional | Protek, Inc. | 07/19/1989SE |
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Questions and answers
When was TANDEM Hip System cleared by the FDA?
TANDEM Hip System (K231448) received a 510(k) decision of Substantially Equivalent on July 19, 2023, 62 days after the submission was received.
What is the product code of K231448?
The FDA product code is LZY – Prosthesis, Hip, Hemi-, Femoral, Metal Ball, a Class II (moderate risk) device regulated under 21 CFR 888.3360.