Innovasive Devices Meniscal Screw
FDA 510(k) K980681 · Innovasive Devices, Inc.
510(k) numberK980681
Submission
- Device name
- Innovasive Devices Meniscal Screw
- Applicant
- Innovasive Devices, Inc.
Marlboro, MA, US - Received
- February 20, 1998
- Decision date
- April 29, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 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 Devices Meniscal Screw cleared by the FDA?
Innovasive Devices Meniscal Screw (K980681) received a 510(k) decision of Substantially Equivalent on April 29, 1998, 68 days after the submission was received.
What is the product code of K980681?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.