FDA.report

19mm Cervical Plate with Cover Plate for 10mm Inte

Primary DI
B064XM21600101
Brand
19mm Cervical Plate with Cover Plate for 10mm Inte
Company
XENCO MEDICAL LLC
Model
XM-216-0010
Published
2018-02-06
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
B064XM21600101PrimaryHIBCC0

GMDN Terms

TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

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

Other Devices From This Company

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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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