FDA.reportPublic FDA data

Anyplus ll Spinal Fixation System

Primary DI
08800322758137
Brand
Anyplus ll Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
GS120-8200
Catalog number
GS120-8200
Device description
Anyplus II Navigation Awl Ø2.6
Published
2026-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWJAwl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800322758137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800322758137088003227581378800322758137

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82432377393udimail@gsmedi.com

Regulatory Flags#

DUNS number
688385418
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
08800322708224Anyplus ll Spinal Fixation SystemGS120-2340GS120-23402026-04-21
08800322727270Anyplus ll Spinal Fixation SystemGS120-5500GS120-55002025-10-14
08800322727287Anyplus ll Spinal Fixation SystemGS120-5501GS120-55012025-10-14
08800322727294Anyplus ll Spinal Fixation SystemGS120-5502GS120-55022025-10-14
08800322727300Anyplus ll Spinal Fixation SystemGS120-5503GS120-55032025-10-14
08800322727317Anyplus ll Spinal Fixation SystemGS120-5504GS120-55042025-10-14
08800322727324Anyplus ll Spinal Fixation SystemGS120-5505GS120-55052025-10-14
08800322727331Anyplus ll Spinal Fixation SystemGS120-5506GS120-55062025-10-14
08800322727348Anyplus ll Spinal Fixation SystemGS120-5507GS120-55072025-10-14
08800322727355Anyplus ll Spinal Fixation SystemGS120-5508GS120-55082025-10-14
08800322750001AnyPlus®GS120-1150GS120-11502026-04-21
08800322758120PYXIS 3D Titanium Cervical Cage, CloseGS166-9020GS166-90202026-04-21
08800322758144Anyplus ll Spinal Fixation SystemGS120-8210GS120-82102026-04-21
08800322758151Anyplus ll Spinal Fixation SystemGS120-8300GS120-83002026-04-21
08800322758168Anyplus ll Spinal Fixation SystemGS120-8310GS120-83102026-04-21
08800322758175Anyplus ll Spinal Fixation SystemGS120-8900GS120-89002026-04-21
08800322758182Anyplus ll Spinal Fixation SystemGS120-8540GS120-85402026-04-21
08800322758199Anyplus ll Spinal Fixation SystemGS120-8545GS120-85452026-04-21
08800322758205Anyplus ll Spinal Fixation SystemGS120-8550GS120-85502026-04-21
08800322758212Anyplus ll Spinal Fixation SystemGS120-8555GS120-85552026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857915007767IM Nail AwlA.M. SURGICAL, INC.HWJ2026-06-10
00840311245376Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWJ2026-04-30
00860015151308EnFix Instrument Kit - CompleteTETROUS, INC.HWJ2026-02-24
00887868287473Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663108126Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663109949InViZia Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663128759PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHWJ2025-11-12
03662663129015Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHWJ2025-11-12
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
00763000674410n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-26
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21
00763000878245n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-20
00840180541050General InstrumentsALPHATEC SPINE, INC.HWJ2025-10-17
00763000885243n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-11
00816342025522AWLPARCUS MEDICAL LLCHWJ2025-09-16
00841732142329GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2025-03-31
00841732142336GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2025-03-31
00841732151642GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2025-03-31
00841732151734GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2025-03-31
00841732160330GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2025-03-31
08800104099977Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HWJ2025-03-17
00841732166745GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2024-12-04
00841732134393GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134409GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134416GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134423GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732135406GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732139411GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07