Ensplint TM Bone Screw
FDA 510(k) K080778 · Sonoma Orthopedic Products, Inc.
510(k) numberK080778
Submission
- Device name
- Ensplint TM Bone Screw
- Applicant
- Sonoma Orthopedic Products, Inc.
Santa Rosa, CA, US - Received
- March 19, 2008
- Decision date
- July 10, 2008
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K161371 | Sonoma Fifth Metatarsal Repair SystemHSB · Traditional | 02/24/2017SE |
| K142945 | Sonoma Fibula Repair SystemHSB · Traditional | 01/22/2015SE |
| K111550 | Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy(X=Dia…HSB · Traditional | 08/19/2011SE |
| K100112 | Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy(X=Dia, Yyy=Length-In MM)HSB · Traditional | 09/28/2010SE |
| K092110 | Waveon Fracture Repair System (Waveon RX)HSB · Traditional | 01/20/2010SE |
| K090304 | Waveon WRX Bone Fixation SystemHRS · Traditional | 08/28/2009SE |
| K081832 | Ensplintcmx Clavicle PinHSB · Traditional | 10/10/2008SE |
| K071809 | Ensplintrx Bone Fixation SystemHRS · Traditional | 02/21/2008SE |
Questions and answers
When was Ensplint TM Bone Screw cleared by the FDA?
Ensplint TM Bone Screw (K080778) received a 510(k) decision of Substantially Equivalent on July 10, 2008, 113 days after the submission was received.
What is the product code of K080778?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.