FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CoLink Afx Plating System
K Number: K181113
·
Decision Jun 15, 2018
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
25
Review Days
49
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CoLink Afx Plating System
- K Number
- K181113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- In2bones USA, LLC
- Date Received
- April 27, 2018
- Decision Date
- June 15, 2018
- 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 In2bones USA, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K233089 | NeoSpan® Compression Implant System | May 24, 2024 | Substantially Equivalent |
| K231236 | IBS-B MIS Beveled Screw System | Jul 27, 2023 | Substantially Equivalent |
| K213698 | CoLink PCR Plating System | May 27, 2022 | Substantially Equivalent |
| K220260 | Hercules Syndesmosis Implant System | Mar 31, 2022 | Substantially Equivalent |
| K212872 | Avenger Radial Head System | Dec 17, 2021 | Substantially Equivalent |
| K213069 | CoLink NeoFuse Plating System | Dec 13, 2021 | Substantially Equivalent |
| K212487 | CoLink Vallux Plating System | Nov 18, 2021 | Substantially Equivalent |
| K203698 | CoLink Sfx Implant System | May 4, 2021 | Substantially Equivalent |
| K210060 | CoLink Mfx Implant System | Mar 12, 2021 | Substantially Equivalent |
| K201636 | Hercules Suture Anchor System | Aug 20, 2020 | Substantially Equivalent |