FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COATED ZT PROXIMAL SLEEVE
K Number: K934412
·
Decision Jun 3, 1994
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
33
Review Days
266
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Basic Information
- Device Name
- COATED ZT PROXIMAL SLEEVE
- K Number
- K934412
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Joint Medical Products Corp.
- Date Received
- September 10, 1993
- Decision Date
- June 3, 1994
- 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 Joint Medical Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K955511 | ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP | Feb 26, 1996 | Substantially Equivalent |
| K954935 | S-ROM FEMORAL HIP STEM - SIZE 14 X 8 | Jan 22, 1996 | Substantially Equivalent |
| K944321 | S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K951726 | S-ROM ZTP UHMWPE ACETABULAR CUP | Jun 21, 1995 | Substantially Equivalent |
| K951084 | S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS | May 31, 1995 | Substantially Equivalent |
| K951000 | ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM | Apr 14, 1995 | Substantially Equivalent |
| K941769 | KNEE PROTHESIS | Feb 1, 1995 | Substantially Equivalent for Some Indications |
| K936037 | S-ROM NOILES CRUCIATE RETAINING KNEE | Oct 3, 1994 | Substantially Equivalent for Some Indications |
| K931676 | S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG | May 18, 1994 | Substantially Equivalent |
| K935078 | S-ROM TOTAL HIP REPLACEMENT SYSTEM | Mar 9, 1994 | Substantially Equivalent for Some Indications |