FDA.reportPublic FDA data

Alignment Gauge Medium

Primary DI
07290115932751
Brand
Alignment Gauge Medium
Company
PREMIA SPINE LTD
Model
86202
Published
2026-06-01
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
QWKProsthesis, Posterior Spinal Elements

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220002000TOPS™ SystemPremia Spine, Ltd.2023-06-15QWK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115932751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115932751072901159327517290115932751

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
649220779
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
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
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
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
07290014381254ProMIS™ Fixation System875112026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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