FDA.reportPublic FDA data

Prodisc C Instrument

Primary DI
00843193115386
Brand
Prodisc C Instrument
Company
Centinel Spine, LLC
Model
03.820.142S
Device description
Prodisc C Inserter Tip for XL/XLD Implants 7mm Height - Sterile
Published
2026-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221848000prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC2022-08-19QLQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843193115386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843193115386008431931153868431931153860843193115386

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant-instrument extension adaptor, single-useA sterile connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a single-use device.

Regulatory Flags#

DUNS number
949024850
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843193102447Prodisc C Instrument03.820.117S2026-09-25
00843193102454Prodisc C, SK, Vivo, Nova Instrument03.820.161S2026-09-25
00843193102461Prodisc C Instrument03.820.153S2026-09-25
00843193102478Prodisc C Instrument03.820.163S2026-09-25
00843193102485Prodisc C Instrument03.820.157S2026-09-25
00843193102492Prodisc C Instrument03.820.167S2026-09-25
00843193102508Prodisc C Instrument03.820.159S2026-09-25
00843193102515Prodisc C Instrument03.820.169S2026-09-25
00843193112699Prodisc C Instrument03.820.1362026-09-25
00843193112705Prodisc C Instrument03.820.1372026-09-25
00843193115300Prodisc C Instrument03.820.130S2026-09-25
00843193115317Prodisc C Instrument03.820.131S2026-09-25
00843193115324Prodisc C Instrument03.820.132S2026-09-25
00843193115331Prodisc C Instrument03.820.133S2026-09-25
00843193115348Prodisc C Instrument03.820.134S2026-09-25
00843193115355Prodisc C Instrument03.820.135S2026-09-25
00843193115362Prodisc C Instrument03.820.140S2026-09-25
00843193115379Prodisc C Instrument03.820.141S2026-09-25
00843193115706Prodisc C InstrumentIN1545S2026-09-25
00843193115713Prodisc C InstrumentIN1546S2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843193115300Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115317Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115324Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115331Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115348Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115355Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115362Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
00843193115379Prodisc C InstrumentCentinel Spine, LLCQLQ2026-09-25
07640139343079BAGUERA® CSpineArt SAQLQ2026-08-19
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