FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
FDA 510(k) K221731 · T.A.G. Medical Products Corporation, Ltd.
510(k) numberK221731
Submission
- Device name
- FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
- Applicant
- T.A.G. Medical Products Corporation, Ltd.
Kibbutz Gaaton, IL - Received
- June 15, 2022
- Decision date
- September 7, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K253858 | GFS - Sterile Screws and Top HatHWC · Special | 08/05/2026SE |
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| K230058 | Bladeless Trocar Artemis Lap CannulaGCJ · Traditional | 04/28/2023SE |
| K210498 | Betta Link Knotless Implant SystemMBI · Special | 03/24/2021SE |
| K202178 | VersaLoop Anchor SystemMBI · Traditional | 11/13/2020SE |
| K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…MBI · Traditional | 05/19/2019SE |
| K143326 | T.A.G. Dental Implant SystemDZE · Traditional | 05/14/2015SE |
| K142653 | G-Lok and G-Lok XL ExtenderMBI · Special | 10/16/2014SE |
| K113297 | Knotilus Anchor SystemMBI · Traditional | 03/02/2012SE |
| K112296 | Lateral ButtonMBI · Traditional | 12/01/2011SE |
Questions and answers
When was FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire cleared by the FDA?
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (K221731) received a 510(k) decision of Substantially Equivalent on September 7, 2022, 84 days after the submission was received.
What is the product code of K221731?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.