SILVERBACK Gorilla Plating System
FDA 510(k) K182148 · Paragon 28, Inc.
510(k) numberK182148
Submission
- Device name
- SILVERBACK Gorilla Plating System
- Applicant
- Paragon 28, Inc.
Englewood, CO, US - Received
- August 8, 2018
- Decision date
- September 7, 2018
- 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 |
|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | 08/28/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | 08/06/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | 08/03/2026SE |
| K253886 | Grappler Suture Anchor PCFD Tether SystemMBI · Traditional | 03/17/2026SE |
| K253591 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Traditional | 03/05/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | 12/19/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | 08/11/2025SE |
| K250952 | Baby Gorilla®/Gorilla® Plating SystemHRS · Traditional | 07/18/2025SE |
| K251850 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Special | 07/14/2025SE |
Questions and answers
When was SILVERBACK Gorilla Plating System cleared by the FDA?
SILVERBACK Gorilla Plating System (K182148) received a 510(k) decision of Substantially Equivalent on September 7, 2018, 30 days after the submission was received.
What is the product code of K182148?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.