FDA Registration
Active
🇺🇸 United States
VQ LSO ECLIPSE AP SM/MD (510010-SM)
Reg #: 1218997
·
FEI: 1218997
·
Expires 2025
Products
1
Proprietary Names
152
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- CORFLEX
- Registration Number
- 1218997
- FEI Number
- 1218997
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 669 EAST INDUSTRIAL PARK, DRIVE
- City
- MANCHESTER
- State
- NH
- ZIP
- 03109
- Country
- US
Owner / Operator
- Firm Name
- Corflex Global, LLC
- Operator Number
- 1218997
- Address
- 669 EAST INDUSTRIAL, PARK DRIVE
- City
- Manchester
- State
- NH
- Postal Code
- 03109
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2013-12-16 |
Proprietary Names
VQ LSO ECLIPSE AP SM/MD (510010-SM)
VQ TRUVERSE LSO PANEL COVER ONLY
LUMBAR STRAP
DISC UNLOADER SPINAL ORTHOSIS L
DISC UNLOADER SPINAL ORTHOSIS M
LACE ALIGN LO COVER KIT
VQ LSO ASCENT AP LG/XL BODY/ LATERALS
VQ TRUVERSE PANEL HOOD & COVER FABRIC ONLY
CORFLEX RANGER SHOULDER STRAP
DISC UNLOADER SPINAL ORTHOSIS XL
REALIGN LSO SIDE PANELS
LACE ALIGN HDPE ANTERIOR PANEL
LACE ALIGN LSO SIDE PANELS
LACE ALIGN SPINAL ORTHOSIS LO PANEL COVER W/PLASTIC
LACE ALIGN NYLON LSO DIE CUT PANEL
DISC UNLOADER 6" FRONT PANEL ONLY S/M
EXPERT PAIN LACE ALIGN LSO PANEL HOOD
VQ LSO ECLIPSE APL LG/XL (510030-LX)
SPINE & PAIN INSTITUTE FL LACE ALIGN LSO PANEL HOOD
FLORIDA SPINE ASSOCIATES LACE ALIGN LSO PLUS PANEL HOOD
IVY SPINE ORTHOPEDICS TLSO PANEL COVER
VQ LSO ASCENT AP+ LG/XL (510020-LX)
DISC UNLOADER SPINAL ORTHOSIS 4XL
E/N LUMBAR SUPPORT BLACK 4XL
VQ LSO ECLIPSE TLSO UNIV (510050)
SC PAIN & SPINE SPECIALISTS LACE ALIGN LSO PANEL HOOD
EMBROIDERY TNC PAIN MANAGEMENT LOGO LSO PANEL
LACE ALIGN SPINAL ORTHOSIS LO PANEL
MSA ORTHOPEDIC LACE ALIGN LO PANEL HOOD
E/N LUMBAR SUPPORT BLACK M
LACE ALIGN SPINAL ORTHOSIS BODY/LATERALS S/M
PINEHURST SURGICAL LACE ALIGN LSO PANEL HOOD
VQ LO ECLIPSE LO PANEL COVER FABRIC ONLY
CORFLEX LACE ALIGN LSO PANEL HOOD & COVER FABRIC ONLY
CORFLEX LACE ALIGN LO PANEL COVER FABRIC ONLY
VQ LSO ECLIPSE PANEL HOOD & COVER FABRIC ONLY
CORFLEX LACE ALIGN LSO PANEL HOOD
E/N LUMBAR SUPPORT BLACK XS
LACE ALIGN SPINAL ORTHOSIS LSO S/M
REALIGN EXTENSION KIT 16"
LACE ALIGN LSO COVER KIT
VQ LSO ASCENT LO PANEL COVER W/PLASTIC
REALIGN LSO PANEL HOOD & COVER FABRIC ONLY
HEALTH FIRST LACE ALIGN LSO PLUS PANEL HOOD
TNC PAIN MANAGEMENT LACE ALIGN LSO PANEL HOOD
LACE ALIGN SPINAL ORTHOSIS BODY/ LATERALS L/XL
E/N LUMBAR SUPPORT BLACK 2XL
ONC LACE ALIGN LSO PANEL HOOD
16" LACE ALIGN EXTENSION KIT
15" EXTENSION KIT LACER BACK ORTHOSIS
PALM TREE LACE ALIGN LSO PANEL HOOD
RESURGENS LACE ALIGN LSO PANEL HOOD
LACE ALIGN SPINAL ORTHOSIS LSO PANEL
ORTHOPAEDIC ASSOCIATES LO PANEL HOOD
CORFLEX RANGER CUFF
OSS REALIGN PANEL HOOD & COVER FABRIC ONLY
VQ LSO ASCENT LSO PANEL COVER W/PLASTIC
E/N LUMBAR SUPPORT BLACK L
VQ LSO ASCENT AP LG/XL (510010-LX)
ORTHOGEORGIA LACE ALIGN LSO PANEL HOOD
TRUVERSE EXTENSION KIT 16" (510090)
OSS REALIGN LSO PANEL HOOD FABRIC ONLY
VQ LSO ASCENT AP+ SM/MD (510020-SM)
VQ LSO ASCENT APL SM/MD (510030-SM)
LACE ALIGN SPINAL ORTHOSIS LSO PLUS L/XL
DISC UNLOADER 6" FRONT PANEL ONLY LG/XL
E/N LUMBAR SUPPORT BLACK 3XL
ORTHOGEORGIA LACE ALIGN LO PANEL COVER
REGIONAL MEDICAL PATRIOT BACK COVER
ADVANCE PAIN LACE ALIGN LO PANEL COVER
EMBROIDERY TNC PAIN MANAGEMENT LOGO TLSO PANEL
LACE ALIGN SPINAL ORTHOSIS LO L/XL
3/8" BLACK FOAM PAD W/1" HOOK TAB
VQ LSO ECLIPSE AP LG/XL (510010-LX)
LACE ALIGN GEL POUCH
REALIGN SPINAL ORTHOSIS LO UNIV
REALIGN LSO HOOD OSS LOGO
LACE ALIGN SPINAL ORTHOSIS LSO L/XL
VQ LSO ASCENT APL LG/XL (510030-LX)
MSA ORTHOPEDIC LACE ALIGN LSO PANEL HOOD
LACE ALIGN LSO SIDE PANELS COVER W/PLASTIC
ORTHOPAEDIC ASSOCIATES LSO PANEL HOOD
CORFLEX LACE ALIGN TLSO PANEL COVER
THE BACK CENTER LACE ALIGN LSO PLUS PANEL HOOD
VQ LSO ECLIPSE AP+ LG/XL (510020-LX)
VQ TRUVERSE APL SPINE LSO PLUS UNIV (510080)
REALIGN SPINAL ORTHOSIS LSO UNIV
PATRIOT BACK BRACE
IVY SPINE ORTHOPEDICS LSO PANEL HOOD
VQ TRUVERSE AP+ SPINE LSO UNIV (510070)
CITRUS SPINE INSTITUTE LACE ALIGN LO PANEL HOOD
CITRUS SPINE INSTITUTE LACE ALIGN LSO PANEL HOOD
LACE ALIGN SPINAL ORTHOSIS TLSO UNIV
LACER BACK GENERIC PULL TAB W/EYELET
BIOSPINE LACE ALIGN LSO PANEL HOOD
CORFLEX LACE ALIGN LSO PANEL COVER FABRIC ONLY
REGIONAL MEDICAL PATRIOT II BACK BRACE UNIVERSAL
CELEBRATION ORTHOPAEDIC HOOD PANEL
HEROLD'S NORTH PHARM LACE ALIGN LSO PANEL HOOD
TNC PAIN MANAGEMENT LACE ALIGN TLSO PANEL HOOD
GEORGIA O&P LACE ALIGN LO PANEL COVER
REALIGN SPINAL ORTHOSIS LSO PLUS UNIV
VQ LSO ASCENT LSO PANEL HOOD
LACE ALIGN PATTERN TACK (LACER GUIDES, ZZ)
LACE ALIGN NYLON TLSO DIE CUT PANEL
GEORGIA O&P LACE ALIGN LSO PANEL HOOD
RALEIGH ORTHOPAEDIC RANGER CUFF
LACE ALIGN SPINAL ORTHOSIS LO S/M
DISC UNLOADER SPINAL ORTHOSIS 2XL
THE SHOULDER CLINIC RANGER CUFF
ADVANCE PAIN LACE ALIGN LSO PANEL HOOD
REALIGN LSO BACK PANEL
REALIGN LSO HOOD NO LOGO
REALIGN LO PANEL COVER ONLY
ORTHOPAEDIC ASSOCIATES TLSO PANEL HOOD
SPINE INST CENTRAL FL LACE ALIGN LSO PANEL HOOD
FLORIDA PAIN MANAGEMENT LACE ALIGN LSO PANEL HOOD
E/N LUMBAR SUPPORT BLACK XL
LDPE MID LENGTH INSERT 3.5" x 4.75"
REALIGN LSO PANEL COVER ONLY
LACE ALIGN TLSO COVER KIT
LDPE EXT LENGTH INSERT 3.5" x 6.75"
LACE ALIGN SPINAL ORTHOSIS LSO PLUS S/M
REALIGN LO PANEL HOOD FABRIC ONLY
REALIGN LO COVER NO LOGO
VQ TRUVERSE AP SPINE LO UNIV (510060)
REGIONAL MEDICAL PATRIOT BACK COVER SUBASSY
VQ LSO ECLIPSE AP+ SM/MD (510020-SM)
VQ LSO ECLIPSE APL SM/MD (510030-SM)
DISC UNLOADER SPINAL ORTHOSIS S
COMPREHENSIVE SPINE LACE ALIGN LSO PANEL HOOD
LACE ALIGN SPINAL ORTHOSIS LSO PANEL COVER W/PLASTIC
INTERVENTIONAL PAIN & SPINE LACE ALIGN LSO PANEL HOOD
VQ TRUVERSE PANEL HOOD FABRIC ONLY
REALIGN LO BACK PANEL
REALIGN WING SET UNIV
LSO BACK PANEL W/ FOAM
DIE OUTLAST LACE ALIGN EXTENSION PANEL
DISC UNLOADER SPINAL ORTHOSIS 3XL
LACE ALIGN NYLON LO DIE CUT PANEL
REALIGN LSO PANEL HOOD FABRIC ONLY
E/N LUMBAR SUPPORT BLACK S
DISC UNLOADER SPINAL ORTHOSIS XS
ALASKA HES RANGER CUFF
ORTHOGEORGIA RANGER CUFF
RESURGENS LACE ALIGN LO PANEL COVER
EMBROIDERY HEALTH FIRST LOGO LSO PANEL (CNTR, 2.5" FRM BTTM)
DISC UNLOADER 6" FRONT PANEL ONLY XS
LACE ALIGN WING SET LARGE
ALASKA ORTHOPEDIC SPECIALISTS RANGER CUFF
VQ LSO ASCENT AP SM/MD (510010-SM)
VQ LSO ASCENT AP SM/MD BODY/LATERALS
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device