Innovasive Suture Bone Fastener with Suture
FDA 510(k) K935321 · Innovasive Devices, Inc.
510(k) numberK935321
Submission
- Device name
- Innovasive Suture Bone Fastener with Suture
- Applicant
- Innovasive Devices, Inc.
Hopkinton, MA, US - Received
- November 4, 1993
- Decision date
- October 19, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K240212 | COGNiTiON Staple SystemJDR · Special | Ortho Solutions UK , Ltd. | 02/23/2024SE |
| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | Novastep | 12/04/2023SE |
More from Novastep
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K983560 | Innovasive Devices Intratunnel Tibial Fixation FastenerMBI · Traditional | 01/28/1999SE |
| 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 |
Questions and answers
When was Innovasive Suture Bone Fastener with Suture cleared by the FDA?
Innovasive Suture Bone Fastener with Suture (K935321) received a 510(k) decision of Substantially Equivalent on October 19, 1994, 349 days after the submission was received.
What is the product code of K935321?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.