FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT
K Number: K844482
·
Decision Feb 19, 1985
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
44
Applicant Total
22
Review Days
92
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Basic Information
- Device Name
- MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT
- K Number
- K844482
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3320
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Advanced Biosearch Assn.
- Date Received
- November 19, 1984
- Decision Date
- February 19, 1985
- Product Code
- JDL
- 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 |
|---|---|---|---|
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | FDA class 3 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDL), ordered by most recent decision date.
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M2A/C2A ACETABULAR SYSTEM
FDA 510(k)
FDA Class 3
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Other Clearances by Advanced Biosearch Assn.
| K Number | Device Name | ||
|---|---|---|---|
| K905514 | AUTOGENESIS(TM) AUTOMATOR | Apr 2, 1991 | Substantially Equivalent |
| K883888 | CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. | Dec 12, 1988 | Substantially Equivalent |
| K854770 | MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM | Feb 11, 1986 | Substantially Equivalent |
| K855030 | CHAMPY BONE PLATES & BONE SCREWS | Jan 30, 1986 | Substantially Equivalent |
| K855031 | MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P | Jan 21, 1986 | Substantially Equivalent |
| K853916 | P.M. HIP-FEMORAL PROSTHESIS | Dec 27, 1985 | Substantially Equivalent |
| K852839 | FREEMAN HIP | Oct 29, 1985 | Substantially Equivalent |
| K853418 | SAFTI-BRACELET | Sep 20, 1985 | Substantially Equivalent |
| K852517 | CLS HIP PROSTHESIS | Sep 18, 1985 | Substantially Equivalent |
| K852699 | FREEMAN ACETABULAR CUP | Sep 5, 1985 | Substantially Equivalent |