FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JOHNSON AND JOHNSON POWER SYSTEM
K Number: K913629
·
Decision Nov 13, 1991
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
55
Applicant Total
22
Review Days
90
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Basic Information
- Device Name
- JOHNSON AND JOHNSON POWER SYSTEM
- K Number
- K913629
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Johnson & Johnson Orthopaedics, Inc.
- Date Received
- August 15, 1991
- Decision Date
- November 13, 1991
- 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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|---|---|---|---|
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| K940190 | ULTIMA UNIPOLAR MODULAR HEAD | Sep 29, 1994 | Substantially Equivalent |
| K933275 | P.F.C. CERAMIC HIP HEAD | Sep 28, 1994 | Substantially Equivalent |
| K932595 | ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR | Sep 20, 1994 | Substantially Equivalent |
| K931655 | P.F.C. BIPOLAR HIP SYSTEM | Jun 9, 1994 | Substantially Equivalent |
| K933867 | UNIVERSAL INSET PATELLA | Jun 6, 1994 | Substantially Equivalent for Some Indications |
| K935262 | P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA | Jun 3, 1994 | Substantially Equivalent for Some Indications |
| K931189 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET | Feb 9, 1994 | Substantially Equivalent |
| K931054 | TRICK MODULAR KNEE TIBIAL TRAY-POROUS | Jan 25, 1994 | Substantially Equivalent |