FDA.report

Ø3.5mm x 40mm Precontoured Cervical Rods

Primary DI
B064XM21700401
Brand
Ø3.5mm x 40mm Precontoured Cervical Rods
Company
XENCO MEDICAL LLC
Model
XM-217-0040
Published
2016-11-04
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
NKGOrthosis, Cervical Pedicle Screw Spinal Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B064XM21700401PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of 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. Sterile 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B064XM3D31223121CancelleX™ 13mm x 12mm x 12mm x 12* Cervical InterbodyXM-3D-312-23122026-02-06
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07290117356876CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-03-23
17290117356880CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-03-23
17290117356897CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-03-23
00763000990695INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC MINIMED, INC.NKG2026-03-22
00763000990701INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990718INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990725INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990732INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990749INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990756INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990763INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990770INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990787INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990794INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990800INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990817INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990824INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990831INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990848INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990855INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990862INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990879INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990886INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990893INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990909INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990916INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990923INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990930INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990947INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990954INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22