FDA Registration
Active
🇺🇸 United States
6895-1344 - Saddle Post Liner
Reg #: 2921578
·
FEI: 2921578
·
Expires 2025
Products
1
Proprietary Names
47
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Registration Number
- 2921578
- FEI Number
- 2921578
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 30031 AHERN AVE
- City
- UNION CITY
- State
- CA
- ZIP
- 94587
- Country
- US
Owner / Operator
- Firm Name
- Mizuho Orthopedic Systems, Inc.
- Operator Number
- 2921578
- Address
- 30031 Ahern Avenue, --
- City
- Union City
- State
- CA
- Postal Code
- 94587
- Country
- US
- Correspondent
- Mark - DeSilets
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2005-02-03 |
Proprietary Names
6895-1344 - Saddle Post Liner
6895-1349 - Extended Saddle Post Liner
6895-1341 - Spar Cover, Shoulder
6895-1342 - Spar Cover, Elbow
6855DPC-1 - HANA DISPOSA-PULL P-POST COVER
5324-23 - COVER, BASE, 12/CS
6986 - PKIT SST CHEST HIP COVERS (6/CS)
5324-13 - COVER, BASE
6985 - PKIT SST BI-LAT CHEST HIP COVERS, 6/CS
6855DPC-50 - HANA DISPOSA-PULL P-POST COVER 50/CS
6947-50 - COVER FOR 6946, 6947 TEMPUR PILLOW 50/CS
6977-796 - CHEST PAD COVER
5929 - 6 in Perineal Post Cover
941 - Seat Drape, 12/Cs
5929DZ - DOZEN, 6" PERINEAL POST COVER
941-1 - DRAPE, SEAT, RECTANGULAR, SINGLE
5844-6 - PKIT, SST, SG COVER W/O PILLOW, 6/CS
7890-1 - PKIT LEVO NON-STERILE CERVICAL, SG
5324-21 - PKIT, SLEEVE, PAD COVER, 12/CS
6985-1 - PKIT,SST BI-LAT CHEST HIP COVERS, 1/EA
5331-1 - PKIT, RWF, NO PILLOW, 1/EA
6856-22 - PROTECTORS, LEG SPAR BALL JOINT, 12/PR
6988A-GT-1-ACP - PKIT, GT, W/ACP, PROAXIS, 1/EA
6977-772 - Hip/Thigh/Hinge Cover
6856LSET - ORTHO LATERAL 3-PC COVER SET
6988SG-6 - ShearGuard Chest Pillow
5812-1 - DRAPE, SEAT, CONTOUR, SINGLE
6856IPC - Ortho Lateral Ilium Post Cover
6988A-GT-ACP - PKIT, GT, W/ACP, PROAXIS, 6/CS
6856LSET-50 - ORTHO LATERAL 3-PC COVER SET 50/CS
7890 - PKIT LEVO NON-STERILE CERVICAL, SG, 6/CS
5331 - PKIT, RWF, NO PILLOW, 6/CS
6986-1 - PATIENT KIT, SST CHEST-HIP COVERS, 1/EA
5817-13 - SHEARGUARD TORSO LIFT COVER, AST, 6/CS
6856LBC - Ortho Lateral Board Protective Pad Cover
6988BLW-12 - CVR, BILATERAL WINGED CHEST PAD (12/CS)
5896-8 - Dual Chest Pad Covers, 12 Pr/Cs
7892-1-1 - Levo Protective Sleeve
5844-13 - PKIT, COVER, SG CHEST PAD, 6/CS
6856LPC - Ortho Lateral Perineal Post Cover
6988HHC-12 - COVER, HIP HINGE (12/CS)
6977-771 - CVR, BILATERAL WINGED CHEST PAD
5844-17 - PKIT, COVER, PAD, 24/CS
6855-13 - COVER, PERINEAL POST, 12 PK
5844-5 - PKIT, TRIOS, SG CHEST, HIP COVERS, 1/EA
5880-119 - PILLOW, CHEST, SHEARGUARD
7892 - Levo Protective Arm Sleeve 12/CS
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device