FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
K Number: K033519
·
Decision Dec 5, 2003
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
441
Review Days
28
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
- CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
- K Number
- K033519
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet, Inc.
- Date Received
- November 7, 2003
- Decision Date
- December 5, 2003
- 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 Biomet, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251270 | Taperloc® Complete Hip Stem | May 19, 2026 | Substantially Equivalent |
| K241014 | Biomet Kirschner Wires (K-Wires) | May 22, 2024 | Substantially Equivalent |
| K222760 | StageOne Select Hip Cement Spacer Molds | Dec 28, 2022 | Substantially Equivalent |
| K221968 | StageOne Shoulder Cement Spacer Molds | Sep 15, 2022 | Substantially Equivalent |
| K213287 | StageOne Knee Cement Spacer Molds | Sep 2, 2022 | Substantially Equivalent |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve | Feb 7, 2022 | Substantially Equivalent |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | Dec 10, 2021 | Substantially Equivalent |
| K210192 | A.L.P.S. Clavicle Plating System | Feb 19, 2021 | Substantially Equivalent |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws | Nov 10, 2020 | Substantially Equivalent |
| K193546 | Distal Centralizers | Sep 25, 2020 | Substantially Equivalent |