FDA.reportPublic FDA data

TOPS™ - 21 L

Primary DI
07290014064003
Brand
TOPS™ - 21 L
Company
PREMIA SPINE LTD
Model
82643
Device description
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
Published
2023-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QWKProsthesis, Posterior Spinal Elements

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290014064003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290014064003072900140640037290014064003

GMDN Terms#

Term, Definition table
TermDefinition
Posterior lumbar spine prosthesisA sterile implantable device designed to replace anatomical structures removed from the posterior aspect of lumbar vertebrae (i.e., the lamina, facet joint, and bony elements) during spinal decompression surgery to provide stability to, and enable normal range of motion of, the lumbar spine. It consists of a two-plate unit positioned in the posterior midline, which connects horizontal rods that are attached laterally to adjacent vertebrae with pedicle screws; the plates include interlocking trunnions for rotational/angular motion. The device may be a single unit or modular assembled during implantation. Dedicated tools for implantation are included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius22 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649220779
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07290115935646Cannulated Screwdriver External sleeve Short882662026-06-01
07290115935653Cannulated Screwdriver Handle Assy XL872452026-06-01
07290115935660Cannulated Screwdriver Inner Shaft XL871542026-06-01
07290115935837MIS Tower Guide86261N2026-06-01
07290014381254ProMIS™ Fixation System875112026-05-25
07290014381261ProMIS™ Fixation System875122026-05-25
07290115935615Counter Torque ST83142N2026-05-25
07290115932553VersaLink Bender825842024-10-01
07290115935479Rod Bender862972024-10-01
07290014381223SST 316 LVM, L=470, Ø1.5 over the K-Wire878512024-09-05
07290115934816K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA873022024-09-05
07290014381148SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power Drill874472024-09-05
07290014381155SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechnique872092024-09-05
07290014381162SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-Wire872082024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07290115934564K-Wire, Blunt Sharp Tip, L=230, Ø1.7mm Shidi-Tec 230PREMIA SPINE LTDQWK2024-09-05
07290115934571K-Wire, Blunt Blunt Tip, L=470, Ø1.7mm Over K-WirePREMIA SPINE LTDQWK2024-09-05
07290115934588K-Wire, Blunt Sharp Tip, L=335, Ø1.7mm KWAPREMIA SPINE LTDQWK2024-09-05
07290115934670Niti#1 Wire, Blunt Sharp Tip, L=470, Ø1.7mm Over K-WirePREMIA SPINE LTDQWK2024-09-05
07290115934687Niti#1 Wire, Blunt Blunt Tip, L=470, Ø1.7mm Over K-WirePREMIA SPINE LTDQWK2024-09-05
07290115934786K-Wire, CrCo, Blunt Sharp Tip, L=340, Ø1.65mm DKWAPREMIA SPINE LTDQWK2024-09-05
07290115934854Niti#1 Wire, Blunt Beveled Tip, L=470, Ø1.7mm Over K-WirePREMIA SPINE LTDQWK2024-09-05
07290115934939K-Wire, Blunt Sharp Tip, L=565, Ø1.6 -0.05 mm P.DrillPREMIA SPINE LTDQWK2024-09-05
07290115934984K-Wire, Blunt Blunt Tip, L=600, Ø1.7mm P.DrillPREMIA SPINE LTDQWK2024-09-05
07290115935042Niti#2 Wire, Blunt Blunt Tip, L=470, Ø1.5mm Over K-WirePREMIA SPINE LTDQWK2024-09-05
07290115935110K-Wire, Blunt Beveled Tip, L=335,Ø 1.7 mm KWAPREMIA SPINE LTDQWK2024-09-05