Encore Linear Hip
FDA 510(k) K972791 · Encore Orthopedics, Inc.
510(k) numberK972791
Submission
- Device name
- Encore Linear Hip
- Applicant
- Encore Orthopedics, Inc.
Austin, TX, US - Received
- July 28, 1997
- Decision date
- January 12, 1998
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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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| K020170 | Keystone Hip System Calcar Replacement Body and Build UpLPH · Special | 02/11/2002SE |
| K013490 | Cemented Calcar Hip SystemLPH · Traditional | 01/17/2002SE |
| K013442 | Pass Spinal SystemKWP · Traditional | 01/15/2002SE |
| K003324 | Plasma Sprayed ShoulderKWS · Traditional | 12/06/2001SE |
| K013431 | Pass Spinal SystemMNI · Special | 11/15/2001SE |
| K013191 | Pass Spinal SystemMNI · Special | 10/24/2001SE |
Questions and answers
When was Encore Linear Hip cleared by the FDA?
Encore Linear Hip (K972791) received a 510(k) decision of Substantially Equivalent for Some Indications on January 12, 1998, 168 days after the submission was received.
What is the product code of K972791?
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.