Neotract Anchor System
FDA 510(k) K073651 · Neotract, Inc.
510(k) numberK073651
Submission
- Device name
- Neotract Anchor System
- Applicant
- Neotract, Inc.
Pleasanton, CA, US - Received
- December 26, 2007
- Decision date
- February 1, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | Teleflex Medical, LLC | 05/06/2026SE |
| K254275 | HyperSuture All Green Extension LineGAT · Traditional | Threadstone, LLC | 03/23/2026SE |
| K254188 | Meniscus VersaflexGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 02/19/2026SE |
| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | Medacta International S.A. | 09/12/2025SE |
| K252201 | HS FiberGAT · Special | Riverpoint Medical | 08/13/2025SE |
| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
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| K200441 | UroLift Advanced Tissue Control (ATC) SystemPEW · Traditional | 06/05/2020SE |
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| K193269 | UroLift System (UL400)PEW · Special | 12/20/2019SE |
| K190377 | UroLift System UL400PEW · Special | 03/21/2019SE |
| K173087 | UroLift System (UL400 and UL500)PEW · Traditional | 12/28/2017SE |
| K172359 | UroLift System (UL500)PEW · Special | 08/18/2017SE |
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Questions and answers
When was Neotract Anchor System cleared by the FDA?
Neotract Anchor System (K073651) received a 510(k) decision of Substantially Equivalent on February 1, 2008, 37 days after the submission was received.
What is the product code of K073651?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.