FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K Number: K122310
·
Decision Jan 18, 2013
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
18
Review Days
170
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Basic Information
- Device Name
- GEMINUS FOSSA SPECIFIC PLATE SYSTEM
- K Number
- K122310
- 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, LLC
- Date Received
- August 1, 2012
- Decision Date
- January 18, 2013
- 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, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K182492 | Geminus Volar Distal Radius Plate System | Oct 10, 2018 | Substantially Equivalent |
| K180744 | Stablyx CMC Arthroplasty Implant System | Apr 11, 2018 | Substantially Equivalent |
| K172688 | Align Radial Head System | Dec 22, 2017 | Substantially Equivalent |
| K171590 | Distal Elbow Plating System | Jun 27, 2017 | Substantially Equivalent |
| K153208 | Internal Joint Stabilizer - Elbow | Dec 31, 2015 | Substantially Equivalent |
| K150675 | Dorsal Spanning Plate | May 12, 2015 | Substantially Equivalent |
| K143624 | Headless Compression Screw System | Jan 13, 2015 | Substantially Equivalent |
| K140892 | DISTAL ELBOW PLATING SYSTEM | Aug 28, 2014 | Substantially Equivalent |
| K140372 | FRAGMENT PLATE SYSTEM | Apr 7, 2014 | Substantially Equivalent |
| K122737 | GEMINUS FOSSA SPECIFIC PLATE SYSTEM | Oct 3, 2012 | Substantially Equivalent |