Innovasive Devices Intratunnel Tibial Fixation Fastener
FDA 510(k) K983560 · Innovasive Devices, Inc.
510(k) numberK983560
Submission
- Device name
- Innovasive Devices Intratunnel Tibial Fixation Fastener
- Applicant
- Innovasive Devices, Inc.
Marlboro, MA, US - Received
- October 13, 1998
- Decision date
- January 28, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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.
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|---|---|---|
| K994269 | Titan RC TackMAI · Special | 01/10/2000SE |
| K993975 | Absolute Absorbable Interference ScrewHWC · Special | 12/20/1999SE |
| K992458 | RC Multisuture Bone Anchor, Model 4453/4454MBI · Traditional | 10/14/1999SE |
| K992377 | RC TackMBI · Traditional | 10/08/1999SE |
| K990454 | Bio-Interference ScrewHWC · Traditional | 07/01/1999SE |
| K984490 | Sutureless AnchorMAI · Traditional | 03/01/1999SE |
| K983056 | Innovasive Tibial FastenerMBI · Traditional | 10/13/1998SE |
| K981340 | Innovasive Devices Meniscal Dart Repair SystemMAI · Traditional | 06/22/1998SE |
| K981193 | Innovasive 3.5MM Metal Roc XS Suture Bone FastenerMBI · Traditional | 06/16/1998SE |
| K980681 | Innovasive Devices Meniscal ScrewHWC · Traditional | 04/29/1998SE |
Questions and answers
When was Innovasive Devices Intratunnel Tibial Fixation Fastener cleared by the FDA?
Innovasive Devices Intratunnel Tibial Fixation Fastener (K983560) received a 510(k) decision of Substantially Equivalent on January 28, 1999, 107 days after the submission was received.
What is the product code of K983560?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.