FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
K Number: K970300
·
Decision Jul 3, 1997
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
108
Review Days
160
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Basic Information
- Device Name
- NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
- K Number
- K970300
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intermedics Orthopedics
- Date Received
- January 24, 1997
- Decision Date
- July 3, 1997
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Intermedics Orthopedics
| K Number | Device Name | ||
|---|---|---|---|
| K970498 | NATURAL-KNEE II REVISION FEMORAL SPACER LUGS | Apr 30, 1997 | Substantially Equivalent |
| K970166 | NATURAL-HIP SYSTEM COCR REVISION STEM | Apr 8, 1997 | Substantially Equivalent |
| K970567 | SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS | Feb 27, 1997 | Substantially Equivalent |
| K964357 | NATURAL-HIP SYSTEM COCR STEM | Jan 27, 1997 | Substantially Equivalent |
| K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA | Jan 16, 1997 | Substantially Equivalent |
| K962190 | PATELLOFEMORAL JOINT PROSTHESIS | Oct 28, 1996 | Substantially Equivalent |
| K963266 | NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED | Oct 15, 1996 | Substantially Equivalent |
| K963155 | INTERMOORE FRACTURE HIP STEM (MODIFY) | Oct 1, 1996 | Substantially Equivalent |
| K962315 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | Sep 3, 1996 | Substantially Equivalent |
| K962289 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | Aug 29, 1996 | Substantially Equivalent |