G-Lok and G-Lok XL Extender
FDA 510(k) K142653 · T.A.G. Medical Products Corporation, Ltd.
510(k) numberK142653
Submission
- Device name
- G-Lok and G-Lok XL Extender
- Applicant
- T.A.G. Medical Products Corporation, Ltd.
Kibbutz Gatton, IL - Received
- September 18, 2014
- Decision date
- October 16, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was G-Lok and G-Lok XL Extender cleared by the FDA?
G-Lok and G-Lok XL Extender (K142653) received a 510(k) decision of Substantially Equivalent on October 16, 2014, 28 days after the submission was received.
What is the product code of K142653?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.