FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTERMEDICS POWER BROACH IMPACTOR
K Number: K895121
·
Decision Sep 11, 1989
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
55
Applicant Total
108
Review Days
27
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Basic Information
- Device Name
- INTERMEDICS POWER BROACH IMPACTOR
- K Number
- K895121
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Intermedics Orthopedics
- Date Received
- August 15, 1989
- Decision Date
- September 11, 1989
- Product Code
- HSZ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Intermedics Orthopedics
| K Number | Device Name | ||
|---|---|---|---|
| K970300 | NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI | Jul 3, 1997 | Substantially Equivalent |
| 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 |