Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CR
FDA 510(k) K090835 · Linvatec Corp.
510(k) numberK090835
Submission
- Device name
- Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CR
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- March 27, 2009
- Decision date
- June 22, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | Arthrex, Inc. | 08/07/2026SE |
| 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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| K092998 | Conmed Linvatec Intercept ImplantMBI · Traditional | 12/23/2009SE |
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| K050497 | Bioscrew Xtralok, 8X35MM & 8X40MM VioletHWC · Special | 03/25/2005SE |
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Questions and answers
When was Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CR cleared by the FDA?
Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CR (K090835) received a 510(k) decision of Substantially Equivalent on June 22, 2009, 87 days after the submission was received.
What is the product code of K090835?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.