Casf Cancellous Bone Screw, BT650
FDA 510(k) K882934 · Terray Manufacturing, Inc.
510(k) numberK882934
Submission
- Device name
- Casf Cancellous Bone Screw, BT650
- Applicant
- Terray Manufacturing, Inc.
Ontario K7s 1l8, CA - Received
- July 13, 1988
- Decision date
- October 13, 1988
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|
| K910874 | Thoracic Anterior Spinal Fixation PlateKWQ · Traditional | 02/03/1992SE |
| K882871 | Casf Drill Guide DG 170LYQ · Traditional | 09/23/1988SN |
| K883193 | Casf Sterilization TrayFSM · Traditional | 08/10/1988SE |
| K883125 | Casf Sterilization TrayFSM · Traditional | 08/10/1988SE |
| K870085 | Anterior Spinal Fixation PlateKWP · Traditional | 06/30/1987SE |
| K870082 | Bone PlateHRS · Traditional | 05/06/1987SE |
| K870083 | Ferray ExtractorHWB · Traditional | 02/26/1987SE |
| K870084 | RD 140 Surgical BenderHXW · Traditional | 01/28/1987SE |
Questions and answers
When was Casf Cancellous Bone Screw, BT650 cleared by the FDA?
Casf Cancellous Bone Screw, BT650 (K882934) received a 510(k) decision of Substantially Equivalent on October 13, 1988, 92 days after the submission was received.
What is the product code of K882934?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.