FDA.reportPublic FDA data

InterBRIDGE

Primary DI
03662663026260
Brand
InterBRIDGE
Company
LDR Spine Usa, Inc.
Model
IB9030R
Catalog number
IB9030R
Device description
IMPLANT HOLDER HANDLE
Published
2017-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PEKSpinous Process Plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEKSpinous Process PlateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663026260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663026260036626630262603662663026260

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-699-3360custserv@ldrspine.com

Regulatory Flags#

DUNS number
615789729
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662663000369Mobi-CMB942RMB942R2018-12-12
03662663002899Avenue TAT9033RAT9033R2017-04-12
03662663002912Avenue TAT9035RAT9035R2017-04-12
03662663033039VFTVF9004RVF9004R2017-05-19
03662663033169VFTVF9105RVF9105R2017-05-19
03662663036863EasyspineES9038RES9038R2018-12-11
03662663037402InterBRIDGEIB9003RIB9003R2018-12-12
03662663041447ROI-TIR9098RIR9098R2018-12-12
03662663041676ROI-AIR9202RIR9202R2017-03-23
03662663043076ROI-AIR9431RIR9431R2018-12-12
03662663043083ROI-AIR9432RIR9432R2018-12-12
03662663043175ROI-CMC9002RMC9002R2017-03-23
03662663043182ROI-CMC9003RMC9003R2017-03-23
03662663043632MC+MC908RMC908R2018-12-11
03662663043656ROI-CMC9092RMC9092R2017-03-23
03662663043663ROI-CMC9093RMC9093R2017-03-23
03662663043670ROI-CMC9094RMC9094R2017-03-23
03662663044165MC+MC937RMC937R2018-12-11
03662663044172MC+MC938RMC938R2018-12-11
03662663044332MC+MC960RMC960R2018-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M9431002210000Minuteman Spinal Simplicity, LLCPEK2026-02-23
M9431002220000Minuteman Spinal Simplicity, LLCPEK2026-02-23
M9431002230000Minuteman Spinal Simplicity, LLCPEK2026-02-23
M9431002240000Minuteman Spinal Simplicity, LLCPEK2026-02-23
10889981146498GeneralSeaspine Orthopedics CorporationPEK2025-12-19
07640185341678ROMEO 2 PAD INSTRUMENTATIONSpineArt SAPEK2025-11-11
B1830712181100KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712181120KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712181140KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712181160KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712200100KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712200120KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712200140KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712200160KeyLift™FLOSPINE LLCPEK2025-02-03
10889981146412NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146436NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146443NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146450NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146467NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146474NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146481NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981096298GeneralSeaspine Orthopedics CorporationPEK2024-06-11
10889981096304GeneralSeaspine Orthopedics CorporationPEK2024-06-11
10889981096311GeneralSeaspine Orthopedics CorporationPEK2024-06-11
00190837137090Aileron TRXLife Spine, Inc.PEK2022-07-11
M9431001040000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13
M9431001000000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13
M9431001010000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13
M9431001020000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13