Conmed Linvatec Presto Preloaded with One or Two #2 Hi-Fi Sutures
FDA 510(k) K092898 · Conmed Linvatec
510(k) numberK092898
Submission
- Device name
- Conmed Linvatec Presto Preloaded with One or Two #2 Hi-Fi Sutures
- Applicant
- Conmed Linvatec
Largo, FL, US - Received
- September 21, 2009
- Decision date
- October 19, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | Arthrex, Inc. | 05/28/2026SE |
| K260294 | SF Push-in AnchorMAI · Traditional | Surgical Fusion Technologies GmbH | 03/27/2026SE |
| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | OSSIO , Ltd. | 02/24/2026SE |
| K251680 | Biosteon® ScrewMAI · Traditional | Biocomposites, Ltd. | 02/17/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | Conmed Corporation | 10/15/2025SE |
| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | OSSIO , Ltd. | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | OSSIO , Ltd. | 05/27/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | Stryker Endoscopy | 05/23/2025SE |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | Stryker Endoscopy | 05/21/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K111779 | Y-Knot All-Suture Anchor Model HF13MBI · Traditional | 08/08/2011SE |
| K102410 | Matryx Interference Screw (5.0-6.5MM)HWC · Traditional | 12/21/2010SE |
| K102339 | Conmed Linvatec Sequent Meniscal Repair DeviceGAT · Traditional | 11/23/2010SE |
| K101100 | Crossft Oc Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503MAI · Traditional | 08/26/2010SE |
| K090560 | Conmed Linvatec Anodized Aluminum Sterilization TraysKCT · Abbreviated | 06/29/2009SE |
| K083161 | Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)HRX · Traditional | 03/27/2009SE |
| K080531 | Conmed Linvatec Microfracture Instrument Sterilization TrayKCT · Traditional | 09/05/2008SE |
| K072291 | Conmed Linvatec Bio Mini-Revo Suture AnchorHWC · Traditional | 07/14/2008SE |
| K080444 | Conmed Linvatec Osprey Drill SystemHBC · Traditional | 04/02/2008SE |
| K073481 | Threvo Anchor, Disposable Driver, Hi-Fi SuturesMBI · Special | 01/07/2008SE |
Questions and answers
When was Conmed Linvatec Presto Preloaded with One or Two #2 Hi-Fi Sutures cleared by the FDA?
Conmed Linvatec Presto Preloaded with One or Two #2 Hi-Fi Sutures (K092898) received a 510(k) decision of Substantially Equivalent on October 19, 2009, 28 days after the submission was received.
What is the product code of K092898?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.