Extremity Bone Screw
FDA 510(k) K963118 · Acu Med, Inc.
510(k) numberK963118
Submission
- Device name
- Extremity Bone Screw
- Applicant
- Acu Med, Inc.
Beaverton, OR, US - Received
- August 12, 1996
- Decision date
- October 10, 1996
- 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 |
|---|---|---|
| K021321 | Wrist Fusion PlateHRS · Traditional | 07/17/2002SE |
| K013616 | Polarus Cap ScrewHSB · Traditional | 12/19/2001SE |
| K012655 | Congruent Bone Plate SystemHRS · Traditional | 11/07/2001SE |
| K992525 | Acumed Modular Shoulder SystemHSD · Traditional | 02/04/2000SE |
| K993657 | Acumed Suture AnchorMBI · Traditional | 01/13/2000SE |
| K980103 | Acumed Suture AnchorMBI · Traditional | 03/16/1998SE |
| K965028 | Acumed Suture WasherHTN · Traditional | 03/17/1997SE |
| K965029 | Stableloc II External FixatorJEC · Traditional | 02/19/1997SE |
| K964500 | Acumed Tension Band PinHTY · Traditional | 12/09/1996SE |
| K963026 | TBDHSB · Traditional | 10/28/1996SE |
Questions and answers
When was Extremity Bone Screw cleared by the FDA?
Extremity Bone Screw (K963118) received a 510(k) decision of Substantially Equivalent for Some Indications on October 10, 1996, 59 days after the submission was received.
What is the product code of K963118?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.