Titanium Spinal Rod System
FDA 510(k) K970635 · Smith & Nephew, Inc., Orthopaedic Div.
510(k) numberK970635
Submission
- Device name
- Titanium Spinal Rod System
- Applicant
- Smith & Nephew, Inc., Orthopaedic Div.
Memphis, TN, US - Received
- February 20, 1997
- Decision date
- August 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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| K963255 | Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial InsertJWH · Traditional | 01/02/1997SN |
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Questions and answers
When was Titanium Spinal Rod System cleared by the FDA?
Titanium Spinal Rod System (K970635) received a 510(k) decision of Substantially Equivalent on August 14, 1997, 175 days after the submission was received.
What is the product code of K970635?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.