Threvo Anchor, Disposable Driver, Hi-Fi Sutures

FDA 510(k) K073481 · Conmed Linvatec

Substantially Equivalent

510(k) numberK073481

Submission

Device name
Threvo Anchor, Disposable Driver, Hi-Fi Sutures
Applicant
Conmed Linvatec
Largo, FL, US
Received
December 11, 2007
Decision date
January 7, 2008
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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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More from ZheJiang Decans Medical Devices Co., Ltd.

510(k)DeviceDecision
K111779Y-Knot All-Suture Anchor Model HF13MBI · Traditional 08/08/2011SE
K102410Matryx Interference Screw (5.0-6.5MM)HWC · Traditional 12/21/2010SE
K102339Conmed Linvatec Sequent Meniscal Repair DeviceGAT · Traditional 11/23/2010SE
K101100Crossft Oc Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503MAI · Traditional 08/26/2010SE
K092898Conmed Linvatec Presto Preloaded with One or Two #2 Hi-Fi SuturesMAI · Special 10/19/2009SE
K090560Conmed Linvatec Anodized Aluminum Sterilization TraysKCT · Abbreviated 06/29/2009SE
K083161Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)HRX · Traditional 03/27/2009SE
K080531Conmed Linvatec Microfracture Instrument Sterilization TrayKCT · Traditional 09/05/2008SE
K072291Conmed Linvatec Bio Mini-Revo Suture AnchorHWC · Traditional 07/14/2008SE
K080444Conmed Linvatec Osprey Drill SystemHBC · Traditional 04/02/2008SE

Questions and answers

When was Threvo Anchor, Disposable Driver, Hi-Fi Sutures cleared by the FDA?

Threvo Anchor, Disposable Driver, Hi-Fi Sutures (K073481) received a 510(k) decision of Substantially Equivalent on January 7, 2008, 27 days after the submission was received.

What is the product code of K073481?

The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.