FDA.reportPublic FDA data

Tube for XL instruments

Primary DI
07290115934779
Brand
Tube for XL instruments
Company
PREMIA SPINE LTD
Model
87259
Published
2024-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QWKProsthesis, Posterior Spinal Elements

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWKProsthesis, Posterior Spinal ElementsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191854000
P220002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191854000Premia Spine XL InstrumentsPremia Spine, Ltd.2019-10-08OLO
P220002000TOPS™ SystemPremia Spine, Ltd.2023-06-15QWK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115934779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115934779072901159347797290115934779

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
649220779
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290115932508Tower Guide ST86261N2026-07-23
07290115935578PER Trial 60890602026-07-22
07290115935691PER Trial 50890972026-07-22
07290115935837MIS Tower Guide86261N2026-06-01
07290115935349TOPS 2 - 21 S889442026-07-09
07290115935356TOPS 2 - 21 M889432026-07-09
07290115935363TOPS 2 - 21 L889422026-07-09
07290115935370TOPS 2 - 30 S889472026-07-09
07290115935387TOPS 2 - 30 M889462026-07-09
07290115935394TOPS 2 - 30 L889452026-07-09
07290115935400TOPS 2 - 38 S889502026-07-09
07290115935417TOPS 2 - 38 M889492026-07-09
07290115935424TOPS 2 - 38 L889482026-07-09
07290115935783TOPS 2 Inserter888932026-07-09
07290115932492Tower ST886062026-06-01
07290115932751Alignment Gauge Medium862022026-06-01
07290115932898Cannulated Screwdriver External sleeve865132026-06-01
07290115934076Tower ST Long Window889742026-06-01
07290115935622Cannulated Screwdriver Inner Shaft Short882642026-06-01
07290115935639Cannulated Screwdriver Handle Assy Short882652026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115932508Tower Guide STPREMIA SPINE LTDQWK2026-07-23
07290115935349TOPS 2 - 21 SPREMIA SPINE LTDQWK2026-07-09
07290115935356TOPS 2 - 21 MPREMIA SPINE LTDQWK2026-07-09
07290115935363TOPS 2 - 21 LPREMIA SPINE LTDQWK2026-07-09
07290115935370TOPS 2 - 30 SPREMIA SPINE LTDQWK2026-07-09
07290115935387TOPS 2 - 30 MPREMIA SPINE LTDQWK2026-07-09
07290115935394TOPS 2 - 30 LPREMIA SPINE LTDQWK2026-07-09
07290115935400TOPS 2 - 38 SPREMIA SPINE LTDQWK2026-07-09
07290115935417TOPS 2 - 38 MPREMIA SPINE LTDQWK2026-07-09
07290115935424TOPS 2 - 38 LPREMIA SPINE LTDQWK2026-07-09
07290115935783TOPS 2 InserterPREMIA SPINE LTDQWK2026-07-09
07290115932751Alignment Gauge MediumPREMIA SPINE LTDQWK2026-06-01
07290115932898Cannulated Screwdriver External sleevePREMIA SPINE LTDQWK2026-06-01
07290115935622Cannulated Screwdriver Inner Shaft ShortPREMIA SPINE LTDQWK2026-06-01
07290115935639Cannulated Screwdriver Handle Assy ShortPREMIA SPINE LTDQWK2026-06-01
07290115935646Cannulated Screwdriver External sleeve ShortPREMIA SPINE LTDQWK2026-06-01
07290115935653Cannulated Screwdriver Handle Assy XLPREMIA SPINE LTDQWK2026-06-01
07290115935660Cannulated Screwdriver Inner Shaft XLPREMIA SPINE LTDQWK2026-06-01
07290115935837MIS Tower GuidePREMIA SPINE LTDQWK2026-06-01
07290115935615Counter Torque STPREMIA SPINE LTDQWK2026-05-25
07290014381179K-Wire, Blunt Sharp Tip, L=352, Ø1.7mm XL Shidi-TecPREMIA SPINE LTDQWK2024-09-05
07290115934946K-Wire, CoCr, Blunt Sharp Tip, L=457, Ø1.7mm XL DKWAPREMIA SPINE LTDQWK2024-09-05
07290014381223SST 316 LVM, L=470, Ø1.5 over the K-WirePREMIA SPINE LTDQWK2024-09-05
07290115934816K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWAPREMIA SPINE LTDQWK2024-09-05
07290014381148SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power DrillPREMIA SPINE LTDQWK2024-09-05
07290014381155SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechniquePREMIA SPINE LTDQWK2024-09-05
07290014381162SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-WirePREMIA SPINE LTDQWK2024-09-05
07290014381186SST 316 LVM, Blunt-Sharp Tip, L=470, Ø1.7 Awl-Shidi (Marked)PREMIA SPINE LTDQWK2024-09-05
07290014381193SST 316 LVM, Blunt-Threaded Tip, L=470, Ø1.7 over the K-WirePREMIA SPINE LTDQWK2024-09-05
07290014381209SST 316 LVM, Blunt-Sharp Tip, Blunt- Sharp Tip, L=470, Ø1.5 over the K-WirePREMIA SPINE LTDQWK2024-09-05