FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Protean Fragment Plating System
K Number: K241815
·
Decision Sep 26, 2024
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
20
Review Days
94
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Basic Information
- Device Name
- Protean Fragment Plating System
- K Number
- K241815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Skeletal Dynamics, Inc.
- Date Received
- June 24, 2024
- Decision Date
- September 26, 2024
- 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
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Other Clearances by Skeletal Dynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254288 | Clavicle Fixation System | Mar 23, 2026 | Substantially Equivalent |
| K252949 | Geminus Volar Distal Radius Plating System | Nov 13, 2025 | Substantially Equivalent |
| K242436 | Proximal Humerus Fixation System | Nov 14, 2024 | Substantially Equivalent |
| K243381 | Total Wrist Arthroplasty System (TWA) | Nov 1, 2024 | Substantially Equivalent |
| K242055 | Freefix Forearm Plating System | Aug 1, 2024 | Substantially Equivalent |
| K240835 | Suture Button Repair System | Jul 19, 2024 | Substantially Equivalent |
| K231447 | Double Internal Joint Stabilizer- Elbow | Dec 15, 2023 | Substantially Equivalent |
| K231188 | ALIGN Radial Head System | Sep 28, 2023 | Substantially Equivalent |
| K231623 | Distal Elbow Plating System | Aug 28, 2023 | Substantially Equivalent |
| K223318 | Internal Joint Stabilizer - Elbow | May 10, 2023 | Substantially Equivalent |