FDA.reportPublic FDA data

30mm x 8mm Paddle Shaver

Primary DI
B064XM22730081
Brand
30mm x 8mm Paddle Shaver
Company
XENCO MEDICAL LLC
Model
XM-227-3008
Device description
30mm x 8mm Paddle Shaver - Reusable
Published
2016-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B064XM22730081PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
858-202-1505sales@xencomedical.com

Regulatory Flags#

DUNS number
079282130
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
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#

Primary DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841523178865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178872Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178889Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178896Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178902Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178919Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178926Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178933Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178940Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178957Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178964Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178971Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178988Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523178995Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179008Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179015Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179022Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179039Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179046Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179053Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179060Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179077Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
00841523179084Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.MAX2026-05-22
08800322740446Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740453Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740460Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740477Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740484Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740491Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740507Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23