FDA.reportPublic FDA data

G Surgical Marksman System

Primary DI
00810240701236
Brand
G Surgical Marksman System
Company
G SURGICAL LLC
Model
PA-7545-55
Device description
7.5 mm x 45 mm Polyaxial Screw, Marksman
Published
2026-11-05
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
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193219000G Surgical Marksman SystemG Surgical, LLC2019-12-17NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810240701236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810240701236008102407012368102407012360810240701236

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
059345832
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
00810240701113G Surgical Marksman SystemGW16402026-11-05
00810240701120G Surgical Marksman SystemPA-40012026-11-05
00810240701137G Surgical Marksman SystemPA-40052026-11-05
00810240701144G Surgical Marksman SystemPA-50052026-11-05
00810240701151G Surgical Marksman SystemPA-50062026-11-05
00810240701168G Surgical Marksman SystemPA-5535-55C2026-11-05
00810240701175G Surgical Marksman SystemPA-6535-552026-11-05
00810240701182G Surgical Marksman SystemPA-6540-552026-11-05
00810240701199G Surgical Marksman SystemPA-6545-552026-11-05
00810240701205G Surgical Marksman SystemPA-6550-552026-11-05
00810240701212G Surgical Marksman SystemPA-6555-552026-11-05
00810240701229G Surgical Marksman SystemPA-7540-552026-11-05
00810240701243G Surgical Marksman SystemPA-7550-552026-11-05
00810240701250G Surgical Marksman SystemPA-8555-552026-11-05
00810240701267G Surgical Marksman SystemSSG0006L2026-11-05
00810240701274G Surgical Marksman SystemSSG00082026-11-05
00810240701281G Surgical Marksman SystemSSG00112026-11-05
00810240701298G Surgical Marksman SystemSSG0019-552026-11-05
00810240701304G Surgical Marksman SystemSSP0001M2026-11-05
M999CSS018030GPS Anterior Cervical Plate SystemCSS-01803CSS-018032016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157125325ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125332ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125349ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125356ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125363ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125370ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125387ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125394ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125400ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125417ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125424ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125448ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125455ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125462ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125479ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125486ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125493ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125509ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125516ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125523ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125530ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125547ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125554ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125561ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125578ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125585ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125592ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125608ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125615ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125622ZAVATION SCREWZavation LLCNKB2026-11-05