Modular Cathcart Fracture System
FDA 510(k) K903084 · Depuy, Inc.
510(k) numberK903084
Submission
- Device name
- Modular Cathcart Fracture System
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- July 12, 1990
- Decision date
- October 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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| K231448 | TANDEM Hip SystemLZY · Traditional | Smith & Nephew, Inc. | 07/19/2023SE |
| 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 |
| 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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| K021478 | Delta ShoulderPHX · Traditional | 11/18/2003SE |
| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
| K032151 | Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special | 09/26/2003SE |
| K020541 | Agility Ankle Revision ProsthesisHSN · Traditional | 05/20/2002SE |
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Questions and answers
When was Modular Cathcart Fracture System cleared by the FDA?
Modular Cathcart Fracture System (K903084) received a 510(k) decision of Substantially Equivalent on October 3, 1990, 83 days after the submission was received.
What is the product code of K903084?
The FDA product code is LZY – Prosthesis, Hip, Hemi-, Femoral, Metal Ball, a Class II (moderate risk) device regulated under 21 CFR 888.3360.