FDA.reportPublic FDA data

Goblin Pedicle Screw System

Primary DI
00810088650970
Brand
Goblin Pedicle Screw System
Company
MEDYNUS, INC.
Model
FPR-50040
Catalog number
FPR-50040
Device description
Reduction 5.5 * 40
Published
2022-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810088650970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810088650970008100886509708100886509700810088650970

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119458950
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00840354203654Impeace Cervical Plate SystemTP.PL.0110TP.PL.01102026-05-06
00840354203661Impeace Cervical Plate SystemTP.PL.0112TP.PL.01122026-05-06
00840354203678Impeace Cervical Plate SystemTP.PL.0114TP.PL.01142026-05-06
00840354203685Impeace Cervical Plate SystemTP.PL.0116TP.PL.01162026-05-06
00840354203692Impeace Cervical Plate SystemTP.PL.0118TP.PL.01182026-05-06
00840354203708Impeace Cervical Plate SystemTP.PL.0120TP.PL.01202026-05-06
00840354203715Impeace Cervical Plate SystemTP.PL.0122TP.PL.01222026-05-06
00840354203722Impeace Cervical Plate SystemTP.PL.0124TP.PL.01242026-05-06
00840354203739Impeace Cervical Plate SystemTP.PL.0126TP.PL.01262026-05-06
00840354203746Impeace Cervical Plate SystemTP.PL.0224TP.PL.02242026-05-06
00840354203753Impeace Cervical Plate SystemTP.PL.0226TP.PL.02262026-05-06
00840354203760Impeace Cervical Plate SystemTP.PL.0228TP.PL.02282026-05-06
00840354203777Impeace Cervical Plate SystemTP.PL.0230TP.PL.02302026-05-06
00840354203784Impeace Cervical Plate SystemTP.PL.0232TP.PL.02322026-05-06
00840354203791Impeace Cervical Plate SystemTP.PL.0234TP.PL.02342026-05-06
00840354203807Impeace Cervical Plate SystemTP.PL.0236TP.PL.02362026-05-06
00840354203814Impeace Cervical Plate SystemTP.PL.0238TP.PL.02382026-05-06
00840354203821Impeace Cervical Plate SystemTP.PL.0240TP.PL.02402026-05-06
00840354203838Impeace Cervical Plate SystemTP.PL.0242TP.PL.02422026-05-06
00840354203845Impeace Cervical Plate SystemTP.PL.0244TP.PL.02442026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
06009699901715Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
06009699901722Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
00810088651052Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651144Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651151Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651168Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651175Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651182Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651366Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651373Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651380Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651397Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651403Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651588Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651595Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651601Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651618Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651625Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651632Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651809Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651816Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651823Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651830Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651847Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651854Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652035Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652042Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652059Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12