Taylor Spatial Frame External Fixation System
FDA 510(k) K970748 · Smith & Nephew, Inc., Orthopaedic Div.
510(k) numberK970748
Submission
- Device name
- Taylor Spatial Frame External Fixation System
- Applicant
- Smith & Nephew, Inc., Orthopaedic Div.
Memphis, TN, US - Received
- March 3, 1997
- Decision date
- May 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
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| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
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| K971414 | Zirconia Prozyr Ceramic 12/14 Global Taper (GT) Femoral HeadsLZO · Traditional | 07/16/1997SE |
| K970751 | Heidelberg External FixatorJDW · Traditional | 04/16/1997SE |
| K970713 | Compass Universal HingeJDW · Traditional | 04/03/1997SE |
| K970351 | Global Taper Spectron Hip StemsJDI · Traditional | 02/28/1997SE |
| 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 Taylor Spatial Frame External Fixation System cleared by the FDA?
Taylor Spatial Frame External Fixation System (K970748) received a 510(k) decision of Substantially Equivalent on May 9, 1997, 67 days after the submission was received.
What is the product code of K970748?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.