FDA.reportPublic FDA data

BAGUERA® C

Primary DI
07640139343079
Brand
BAGUERA® C
Company
SpineArt SA
Model
CDP-IN 00 03-N
Device description
PUSHER
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QLQManual Instruments Designed For Use With Total Disc Replacement Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLQManual Instruments Designed For Use With Total Disc Replacement DevicesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640139343079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640139343079076401393430797640139343079

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483016148
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
07640139343185BAGUERA C INSTRUMENTATIONCDP-IN 30 01-N2026-08-27
07640221370884TRYPTIK® TiTRY-BX 40 01-N2026-08-27
07640178972452ROMEO posterior osteosynthesis systemNAV-IN 01 00-NNAV-IN 01 00-N2019-01-31
07640221370891BAGUERA® CBAG-CT 13 05-S2026-08-21
07640221370907BAGUERA® CBAG-CT 13 06-S2026-08-21
07640221370914BAGUERA® CBAG-CT 13 07-S2026-08-21
07640221370921BAGUERA® CBAG-CT 14 05-S2026-08-21
07640221370938BAGUERA® CBAG-CT 14 06-S2026-08-21
07640221370945BAGUERA® CBAG-CT 14 07-S2026-08-21
07640221370952BAGUERA® CBAG-CT 16 05-S2026-08-21
07640221370969BAGUERA® CBAG-CT 16 06-S2026-08-21
07640221370976BAGUERA® CBAG-CT 16 07-S2026-08-21
07640221370525BAGUERA® CCDP-IN 00 07-N2026-08-19
07640221370532BAGUERA® CCDP-IN 00 06-N2026-08-19
07640221370549BAGUERA® CCDP-IN 61 00-N2026-08-19
07640221370556BAGUERA® CCDP-IN 60 01-N2026-08-19
07640221370563BAGUERA® CCDP-IN SM 05-N2026-08-19
07640221370570BAGUERA® CCDP-IN ME 05-N2026-08-19
07640221370587BAGUERA® CCDP-IN LA 05-N2026-08-19
07640221370594BAGUERA® CCDP-IN SM 06-N2026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221370525BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370532BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370549BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370556BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370563BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370570BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370587BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370594BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370600BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370617BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370624BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370631BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370648BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370655BAGUERA® CSpineArt SAQLQ2026-08-19
07640221370877BAGUERA® CSpineArt SAQLQ2026-08-19
00843193111838Prodisc L InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112323Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112330Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112347Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112354Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112361Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119926Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119933Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119940Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119957Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119964Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119971Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119988Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119995Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193120007Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08