FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RETROGRADE PEDIATRIC NAIL
K Number: K980854
·
Decision Aug 11, 1998
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
85
Review Days
159
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
- RETROGRADE PEDIATRIC NAIL
- K Number
- K980854
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Encore Orthopedics, Inc.
- Date Received
- March 5, 1998
- Decision Date
- August 11, 1998
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTY), ordered by most recent decision date.
ZipToe Hammertoe Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Impact PEEK Union Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
RONAVIS FX (FX-001)
FDA 510(k)
FDA Class 2
·Orthopedic
PediFlex Flexible Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
Impact PEEK Union Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
Biomet Kirschner Wires (K-Wires)
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Encore Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032905 | 3DKNEE POROUS COATED FEMORAL COMPONENT | Jul 6, 2004 | Substantially Equivalent |
| K020114 | 3D KNEE | Jul 12, 2002 | Substantially Equivalent |
| K020741 | UNICONDYLAR KNEE | Jun 4, 2002 | Substantially Equivalent |
| K020236 | MODIFICATION TO PASS SPINAL SYSTEM | Feb 14, 2002 | Substantially Equivalent |
| K020170 | KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP | Feb 11, 2002 | Substantially Equivalent |
| K013490 | CEMENTED CALCAR HIP SYSTEM | Jan 17, 2002 | Substantially Equivalent |
| K013442 | PASS SPINAL SYSTEM | Jan 15, 2002 | Substantially Equivalent |
| K003324 | PLASMA SPRAYED SHOULDER | Dec 6, 2001 | Substantially Equivalent |
| K013431 | PASS SPINAL SYSTEM | Nov 15, 2001 | Substantially Equivalent |
| K013191 | PASS SPINAL SYSTEM | Oct 24, 2001 | Substantially Equivalent |