FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLACK OVAL-TOP TORP/PORP
K Number: K934107
·
Decision Jun 8, 1994
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
87
Review Days
289
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Basic Information
- Device Name
- BLACK OVAL-TOP TORP/PORP
- K Number
- K934107
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3495
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew Richards, Inc.
- Date Received
- August 23, 1993
- Decision Date
- June 8, 1994
- Product Code
- ETA
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ETA | Replacement, Ossicular Prosthesis, Total | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETA), ordered by most recent decision date.
mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50
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Other Clearances by Smith & Nephew Richards, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K965224 | EMPOWER ANTERIOR DIRECT SCREWS | May 8, 1997 | Substantially Equivalent |
| K963509 | GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON | Jan 27, 1997 | Substantially Equivalent |
| K960444 | FINN ROD TO ROD CONNECTOR | Jan 24, 1997 | Substantially Equivalent |
| K964163 | TRIMAX NAIL SYSTEM | Dec 27, 1996 | Substantially Equivalent |
| K962557 | GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT | Dec 5, 1996 | Substantially Equivalent for Some Indications |
| K963486 | REVISION HIP SYSTEM | Nov 27, 1996 | Substantially Equivalent |
| K962541 | REFLECTION ACETABULAR REINFORCEMENT RINGS | Sep 17, 1996 | Substantially Equivalent |
| K962808 | ILIZAROV EXTERNAL FIXATION SYSTEM | Aug 19, 1996 | Substantially Equivalent |
| K962137 | GENESIS II CONSTRAINED SYSTEM | Aug 2, 1996 | Substantially Equivalent |
| K955767 | COFIED MODULAR SHOULDER SYSTEM | Apr 8, 1996 | Substantially Equivalent for Some Indications |