Ez-Fix Small Cannulated Screw System
FDA 510(k) K962987 · Biodynamic Technologies, Inc.
510(k) numberK962987
Submission
- Device name
- Ez-Fix Small Cannulated Screw System
- Applicant
- Biodynamic Technologies, Inc.
Deerfield Beach, FL, US - Received
- August 1, 1996
- Decision date
- November 4, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K990436 | Ultimax Trochanteric Intramedullary Rod SystemHSB · Traditional | 03/31/1999SE |
| K990513 | Ultimax Cortical Bone ScrewsHWC · Traditional | 03/17/1999SE |
| K990481 | Ultimax Distal Radial (Volar) Locking Plate SystemHRS · Traditional | 03/17/1999SE |
| K981230 | Ultimax Distal Femoral Intramedullary Rod SystemHSB · Traditional | 06/01/1998SE |
| K980102 | Bti Humeral Intramedullary Rod SystemHSB · Traditional | 04/03/1998SE |
| K974756 | Bti Large (7.0MM) Cannulated Transfixing ScrewsHWC · Traditional | 03/12/1998SN |
| K972403 | Bti Cortical Bone ScrewsHWC · Traditional | 08/29/1997SE |
| K970897 | Bti Distal Femoral Intramedullary Rod SystemHSB · Traditional | 04/21/1997SE |
| K962706 | Ez-Fix Cannulated Screw SystemHWC · Traditional | 11/13/1996SE |
| K962846 | Ez-Fix Compression Hip/Supracondylar Screw (CHS) SystemLXT · Traditional | 10/23/1996SE |
Questions and answers
When was Ez-Fix Small Cannulated Screw System cleared by the FDA?
Ez-Fix Small Cannulated Screw System (K962987) received a 510(k) decision of Substantially Equivalent on November 4, 1996, 95 days after the submission was received.
What is the product code of K962987?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.