FDA.reportPublic FDA data

NA

Primary DI
10705034568614
Brand
NA
Company
DEPUY SPINE, LLC
Model
698344469
Catalog number
698344469
Device description
MODIFIED INSTRUMENT TRIAL DRILL GUIDE, LARGE 4° 9mm
Published
2022-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034568614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503456861410705034568614

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
107105876
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034471716N/A6983411716983411712022-10-07
10705034570105N\A6983447336983447332022-10-07
10705034570211N/A6983447246983447242022-10-07
10705034570228N\A6983447346983447342022-10-07
10705034570433N/A6983447266983447262022-10-07
10705034570501N\A6983447326983447322022-10-07
10705034570624N/A6983447286983447282022-10-07
10705034570693N\A6983447316983447312022-10-07
10705034570723N/A6983447276983447272022-10-07
10705034458267N/A6983393806983393802022-02-02
10705034137049BENGAL1873011131873011132015-09-24
10705034137056BENGAL1873011141873011142015-09-24
10705034137063BENGAL1873011151873011152015-09-24
10705034137070BENGAL1873011161873011162015-09-24
10705034585321TRIALTIS Spine System5560-12-4560FS5560124560FS2026-05-18
10705034585796TRIALTIS Spine System5560-12-4560S5560124560S2026-05-18
10705034604466TRIALTIS Spine System5560-12-7025CS5560127025CS2026-05-18
10705034359007SPOTLIGHT2829509002829509002016-06-30
10705034217727PIPELINE2871050612871050612019-06-06
10705034217789PIPELINE2871050852871050852019-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207435MSIModern Surgical Instruments LLCLXH2026-07-14
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
08809695601903AnyPlus®GS Medical Co., Ltd.LXH2026-04-21
08800322742945PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742952PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742969PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742976PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742983PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742990PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743003PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743010PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743027PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743034PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743041PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743058PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743065PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743072PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743089PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743096PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743102PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743119PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743126PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743133PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743140PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743157PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743171PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743188PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743195PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743201PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322743218PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18