FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PASS SPINAL SYSTEM
K Number: K013442
·
Decision Jan 15, 2002
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
85
Review Days
90
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Basic Information
- Device Name
- PASS SPINAL SYSTEM
- K Number
- K013442
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Encore Orthopedics, Inc.
- Date Received
- October 17, 2001
- Decision Date
- January 15, 2002
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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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 |
| 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 |
| K011856 | RADIOGRAPHIC MARKERS | Aug 22, 2001 | Substantially Equivalent |