Conmed Linvatec Microfracture Instrument Sterilization Tray
FDA 510(k) K080531 · Conmed Linvatec
510(k) numberK080531
Submission
- Device name
- Conmed Linvatec Microfracture Instrument Sterilization Tray
- Applicant
- Conmed Linvatec
Largo, FL, US - Received
- February 26, 2008
- Decision date
- September 5, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code KCT
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|---|---|---|---|
| K253988 | LiteSet TraysKCT · Traditional | Nobel Biocare AB | 09/08/2026SE |
| K261935 | Surgical and Prosthetic TraysKCT · Traditional | Dentsply Sirona, Inc. | 09/04/2026SE |
| K253187 | SteriBest® Sterilization Tray SystemKCT · Traditional | Mastel Surgical | 06/18/2026SE |
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | Institut Straumann AG | 06/03/2026SE |
| K252854 | SteriTite Container System with MediTray ProductsKCT · Traditional | Case Medical, Inc. | 06/03/2026SE |
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional | DePuy Mitek, Inc. | 02/26/2026SE |
| K251614 | Stainless Steel Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 02/06/2026SE |
| K251756 | Sterilization TraysKCT · Traditional | Paragon Implant Mfg., LLC | 11/14/2025SE |
| K251300 | Plastic Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 07/22/2025SE |
| K243425 | Guided DAS Surgical KitKCT · Traditional | Talladium España, SL | 07/22/2025SE |
More from Talladium España, SL
| 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 |
| K092898 | Conmed Linvatec Presto Preloaded with One or Two #2 Hi-Fi SuturesMAI · Special | 10/19/2009SE |
| 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 |
| 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 Microfracture Instrument Sterilization Tray cleared by the FDA?
Conmed Linvatec Microfracture Instrument Sterilization Tray (K080531) received a 510(k) decision of Substantially Equivalent on September 5, 2008, 192 days after the submission was received.
What is the product code of K080531?
The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.