Plus Orthopedics Cemented Hip Stem
FDA 510(k) K031165 · Plus Orthopedics
510(k) numberK031165
Submission
- Device name
- Plus Orthopedics Cemented Hip Stem
- Applicant
- Plus Orthopedics
Round Rock, TX, US - Received
- April 14, 2003
- Decision date
- June 6, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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| K070928 | Ceramic Ball Heads, 28, 32 and 36 MMLZO · Traditional | 08/01/2007SE |
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| K070278 | Polarcup Dual Mobility SystemLPH · Traditional | 04/16/2007SE |
| K063578 | Promos Modular Shoulder SystemHSD · Traditional | 03/02/2007SE |
| K061362 | Pigalileo Total Knee Replacement (TKR) SystemHAW · Traditional | 10/06/2006SE |
| K032126 | Promos ShoulderHSD · Traditional | 01/08/2004SE |
| K033763 | Modification to Slim Gliding Nail SystemKTT · Special | 12/18/2003SE |
| K032709 | Modular Plus Hip StemLWJ · Special | 09/23/2003SE |
| K032548 | Ip-Xs Compression Nail SystemHSB · Traditional | 09/10/2003SE |
| K032215 | Vks/Tc-Plus Revision KneeJWH · Special | 08/08/2003SE |
Questions and answers
When was Plus Orthopedics Cemented Hip Stem cleared by the FDA?
Plus Orthopedics Cemented Hip Stem (K031165) received a 510(k) decision of Substantially Equivalent on June 6, 2003, 53 days after the submission was received.
What is the product code of K031165?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.