FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT
K Number: K954517
·
Decision Oct 27, 1995
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
73
Applicant Total
14
Review Days
29
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Basic Information
- Device Name
- TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT
- K Number
- K954517
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3450
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trebay Medical Corp.
- Date Received
- September 28, 1995
- Decision Date
- October 27, 1995
- Product Code
- ETB
- 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 |
|---|---|---|---|
| ETB | Prosthesis, Partial Ossicular Replacement | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETB), ordered by most recent decision date.
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Trebay Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K955704 | TREBAY MICRODEBRIDER SYSTEM | Jan 30, 1996 | Substantially Equivalent |
| K955560 | TREBAY SCOPE IRRIGATED CLEARING SLEEVE | Dec 22, 1995 | Substantially Equivalent |
| K955294 | SOF - ABRASION BUR | Dec 22, 1995 | Substantially Equivalent |
| K955447 | TYMPANOSTOMY TUBE | Dec 21, 1995 | Substantially Equivalent |
| K954912 | TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) | Dec 6, 1995 | Substantially Equivalent |
| K954795 | AT2 & DOYLE STYLE (C-FLEX) VENT TUBES | Nov 15, 1995 | Substantially Equivalent |
| K954796 | MICRO-INGRESSOR HANDIPIECE | Nov 6, 1995 | Substantially Equivalent |
| K954518 | TREBAY TOTAL RECTANGULAR HEAD | Oct 27, 1995 | Substantially Equivalent |
| K954715 | MICRO-PLANER HANDPIECE | Oct 27, 1995 | Substantially Equivalent |
| K952226 | C-FLEX SEPTAL SPLINTS | Aug 11, 1995 | Substantially Equivalent |