Bti Large (7.0MM) Cannulated Transfixing Screws
FDA 510(k) K974756 · Biodynamic Technologies, Inc.
510(k) numberK974756
Submission
- Device name
- Bti Large (7.0MM) Cannulated Transfixing Screws
- Applicant
- Biodynamic Technologies, Inc.
Deerfield Beach, FL, US - Received
- December 19, 1997
- Decision date
- March 12, 1998
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
| 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 |
| K962987 | Ez-Fix Small Cannulated Screw SystemHWC · Traditional | 11/04/1996SE |
| K962846 | Ez-Fix Compression Hip/Supracondylar Screw (CHS) SystemLXT · Traditional | 10/23/1996SE |
Questions and answers
When was Bti Large (7.0MM) Cannulated Transfixing Screws cleared by the FDA?
Bti Large (7.0MM) Cannulated Transfixing Screws (K974756) received a 510(k) decision of Substantially Equivalent for Some Indications on March 12, 1998, 83 days after the submission was received.
What is the product code of K974756?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.