FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Baby Gorilla®/Gorilla® Plating System
K Number: K250952
·
Decision Jul 18, 2025
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
50
Review Days
112
Basic Information
- Device Name
- Baby Gorilla®/Gorilla® Plating System
- K Number
- K250952
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paragon 28, Inc.
- Date Received
- March 28, 2025
- Decision Date
- July 18, 2025
- Product Code
- HRS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.
I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
FDA 510(k)
FDA Class 2
·Orthopedic
Exalta Proximal Tibia Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
APTUS Clavicle System 2.8
FDA 510(k)
FDA Class 2
·Orthopedic
Pectus Blu System
FDA 510(k)
FDA Class 2
·Orthopedic
Xpert PFP
FDA 510(k)
FDA Class 2
·Orthopedic
Avanti Distal Elbow ORIF System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Paragon 28, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253886 | Grappler Suture Anchor PCFD Tether System | Mar 17, 2026 | Substantially Equivalent |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Mar 5, 2026 | Substantially Equivalent |
| K253613 | Monkey Rings External Ring Fixation System | Dec 19, 2025 | Substantially Equivalent |
| K252106 | External Fixation Mini Rail System | Sep 30, 2025 | Substantially Equivalent |
| K251862 | External Fixation Bone Distractor | Aug 11, 2025 | Substantially Equivalent |
| K251850 | Phantom® Hindfoot TTC/TC Nail System | Jul 14, 2025 | Substantially Equivalent |
| K250641 | APEX 3D Total Ankle Replacement System | May 1, 2025 | Substantially Equivalent |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Nov 1, 2024 | Substantially Equivalent |
| K234128 | Phantom Fibula Nail System | Aug 22, 2024 | Substantially Equivalent |
| K241864 | Grappler Interference Screw System | Jul 25, 2024 | Substantially Equivalent |