Endotine Forehead Triple Device
FDA 510(k) K042078 · Coapt Systems, Inc.
510(k) numberK042078
Submission
- Device name
- Endotine Forehead Triple Device
- Applicant
- Coapt Systems, Inc.
Palo Alto, CA, US - Received
- August 2, 2004
- Decision date
- August 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
|---|---|---|
| K083783 | VF LiquigelMIX · Traditional | 09/11/2009SE |
| K080956 | Modification to VF Gel PlusMIX · Special | 04/25/2008SE |
| K071663 | VF Gel PlusMIX · Traditional | 02/15/2008SE |
| K060249 | Ultratine ForeheadHWC · Traditional | 06/12/2006SE |
| K060248 | Ultratine TransblephHWC · Traditional | 06/12/2006SE |
| K060828 | Modification to Endotine RibbonGAM · Special | 04/19/2006SE |
| K051415 | Endotine RibbonGAM · Traditional | 06/23/2005SE |
| K050611 | Endotine RibbonGAM · Special | 04/06/2005SE |
| K042796 | Endotine Transbleph 3.0/3.5 DeviceHWC · Special | 11/05/2004SE |
| K041835 | Endotine Midface B 4.5 DeviceHWC · Traditional | 09/28/2004SE |
Questions and answers
When was Endotine Forehead Triple Device cleared by the FDA?
Endotine Forehead Triple Device (K042078) received a 510(k) decision of Substantially Equivalent on August 27, 2004, 25 days after the submission was received.
What is the product code of K042078?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.