FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESKA MODULAR HIP SYSTEM
K Number: K993027
·
Decision Apr 6, 2000
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
2
Review Days
210
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Basic Information
- Device Name
- ESKA MODULAR HIP SYSTEM
- K Number
- K993027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Specs USA, Inc.
- Date Received
- September 9, 1999
- Decision Date
- April 6, 2000
- 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 Specs USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K946349 | STENODOC | May 24, 1996 | Substantially Equivalent |