Global Taper Spectron Hip Stems
FDA 510(k) K970351 · Smith & Nephew, Inc., Orthopaedic Div.
510(k) numberK970351
Submission
- Device name
- Global Taper Spectron Hip Stems
- Applicant
- Smith & Nephew, Inc., Orthopaedic Div.
Memphis, TN, US - Received
- January 30, 1997
- Decision date
- February 28, 1997
- 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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| K970748 | Taylor Spatial Frame External Fixation SystemKTT · Traditional | 05/09/1997SE |
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| K970337 | Ha Global Taper (GT) Tapered Hip StemMEH · Traditional | 02/28/1997SE |
| K963255 | Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial InsertJWH · Traditional | 01/02/1997SN |
| K962784 | Ultium Spinal Plating SystemMNH · Traditional | 10/02/1996SN |
Questions and answers
When was Global Taper Spectron Hip Stems cleared by the FDA?
Global Taper Spectron Hip Stems (K970351) received a 510(k) decision of Substantially Equivalent on February 28, 1997, 29 days after the submission was received.
What is the product code of K970351?
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.