FDA.report

Cervical Interbody 15mm x 13mm x 7mm Packaging

Primary DI
B064XM11215071
Brand
Cervical Interbody 15mm x 13mm x 7mm Packaging
Company
XENCO MEDICAL LLC
Model
XM-112-1507
Device description
Cervical Interbody 15mm x 13mm x 7mm
Published
2015-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B064XM11215071PrimaryHIBCC0

GMDN Terms

TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
858-202-1505sales@xencomedical.com

Regulatory Flags

DUNS number
079282130
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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B064XM3D31225061CancelleX™ 15mm x 13mm x 6mm x 12* Cervical InterbodyXM-3D-312-25062026-02-06
B064XM3D31225071CancelleX™ 15mm x 13mm x 7mm x 12* Cervical InterbodyXM-3D-312-25072026-02-06
B064XM3D31225081CancelleX™ 15mm x 13mm x 8mm x 12* Cervical InterbodyXM-3D-312-25082026-02-06
B064XMPHCP6100818mm One Level Cervical PlateXM-PH-CP6-10082026-02-06
B064HB11200101Tube GuardHB-112-00102023-08-07
B064MPE010101Saratoga Cervical BraceMPE010102023-08-07
B064MPE010401Tahiti Lumbar BraceMPE010402023-08-07
B064XM11510001Pedicle Screw Instruments KitXM-115-10002022-08-11
B064XM1232345123mm x 10mm PLIF Trial Kit 12, 13, 14, 15 mm HeightsXM-123-23452015-10-28
B064XM1272345127mm x 12mm TLIF Trial Kit 12, 13, 14, 15 mm HeightsXM-127-23452015-10-28
B064XM1278901127mm x 12mm TLIF Trial Kit 8, 9, 10, 11 mm HeightsXM-127-89012015-10-28
B064XM1282345128mm x 11mm Oblique Trials 12, 13, 14, 15 mm HeightsXM-128-23452016-07-06
B064XM1288901128mm x 11mm Oblique Trial Kit 8, 9, 10, 11 mm HeightsXM-128-89012015-10-28
B064XM21565501Ø6.5mm x 50mm Pedicle Screw with Set Screw PackageXM-215-65502015-10-27
B064XM21565551Ø6.5mm x 55mm Pedicle Screw with Set Screw PackageXM-215-65552015-10-27
B064XM21575251Ø7.5mm x 25mm Pedicle Screw with Set Screw PackageXM-215-75252015-10-27
B064XM21575271Ø7.5mm x 27mm Pedicle Screw with Set Screw PackageXM-215-75272015-11-03
B064XM21575301Ø7.5mm x 30mm Pedicle Screw with Set Screw PackageXM-215-75302015-11-03
B064XM21575321Ø7.5mm x 32mm Pedicle Screw with Set Screw PackageXM-215-75322015-11-03

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