Syntec-Taichung Non-Sterile Unreamed Interlocking Nail System
FDA 510(k) K984602 · Syntec Scientific Corp.
510(k) numberK984602
Submission
- Device name
- Syntec-Taichung Non-Sterile Unreamed Interlocking Nail System
- Applicant
- Syntec Scientific Corp.
Chang Hua, TW - Received
- December 28, 1998
- Decision date
- March 5, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Syntec-Taichung Non-Sterile Unreamed Interlocking Nail System cleared by the FDA?
Syntec-Taichung Non-Sterile Unreamed Interlocking Nail System (K984602) received a 510(k) decision of Substantially Equivalent on March 5, 1999, 67 days after the submission was received.
What is the product code of K984602?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.