FDA.report

EXPEDIUM

Primary DI
10705034026954
Brand
EXPEDIUM
Company
Medos International Sàrl
Model
175412955
Catalog number
175412955
Device description
EXPEDIUM SPINE SYSTEM POLYAXIAL BOLT, STANDARD 9 x 55mm
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10705034026954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1070503402695410705034026954

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
482661753
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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10886705022649RIGIDLOOP2320092320092015-09-01
10886705022656RIGIDLOOP2320112320112015-09-01
10886705022663RIGIDLOOP2320142320142015-09-01
10886705022670RIGIDLOOP2320162320162015-09-01
10886705022687RIGIDLOOP2320172320172015-09-01
10886705022694RIGIDLOOP2320182320182015-09-01
10886705022700RIGIDLOOP2320192320192015-09-01
10886705022717RIGIDLOOP2320212320212015-09-01
10886705022724RIGIDLOOP2320222320222015-09-01
10886705022731RIGIDLOOP2320232320232015-09-01
10886705022755RIGIDLOOP2320282320282015-09-01
10886705022830RIGIDLOOP2320372320372015-09-01
10886705024070RIGIDLOOP2180342180342015-09-01
10886705024094RIGIDLOOP2324472324472015-09-01
10886705024100RIGIDLOOP2324482324482015-09-01
10886705024117RIGIDLOOP2324492324492015-09-01
10886705026012TRUESPAN ORTHOCORD2281512281512016-07-07
10886705026029TRUESPAN ORTHOCORD2281522281522016-07-07
10886705026036TRUESPAN ORTHOCORD2281602281602016-07-07
10886705026043TRUESPAN ORTHOCORD2281612281612016-07-07

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00840493418711RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418728RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418735RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418742RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418759RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418766RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418773RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418780RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418797RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418803RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418810RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418827RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418834RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418841RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418858RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418865RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418872RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418889RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418896RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418902RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418919RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418926RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418933RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418940RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418957RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418964RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00840493418971RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-03-24
00190837124458ArxLife Spine, Inc.NKB2026-03-23
00190837124465ArxLife Spine, Inc.NKB2026-03-23