Anyplus II Spinal Fixation System

Primary DI
08800322740460
Brand
Anyplus II Spinal Fixation System
Company
GS Medical Co., Ltd.
Model
3885-7550
Catalog number
3885-7550
Device description
The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, reduction screw, canulated screws, long arm screws, cortical screws, and a set screw). The screws are available with diameters ranging from 4.5 to 10.5mm, and lengths ranging from 20-100mm in 5mm increments. They are available in noncannulated, cannulated, and longarm geometries with both mono and poly types for each geometry option. All AnyPlus II Spinal Fixation System implant components are manufactured from Ti6AI4V ELI according to ASTM F136. These implants are supplied non-sterile and are not reusable. The instruments in this system are supplied non-sterile, are reusable, and patient contacting materials are fabricated from Precipitation Hardened Stainless Steels (STS630 and STS555) that complies with ASTM F899.
Published
2025-12-23
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240350000AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.2024-04-03NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800322740460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800322740460088003227404608800322740460

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
false
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
08800322740446Anyplus II Spinal Fixation System3885-75403885-75402025-12-23
08800322740453Anyplus II Spinal Fixation System3885-75453885-75452025-12-23
08800322740477Anyplus II Spinal Fixation System3885-75553885-75552025-12-23
08800322740484Anyplus II Spinal Fixation System3885-75603885-75602025-12-23
08800322740491Anyplus II Spinal Fixation System3885-75653885-75652025-12-23
08800322740507Anyplus II Spinal Fixation System3885-75703885-75702025-12-23
08800322740514Anyplus II Spinal Fixation System3885-75753885-75752025-12-23
08800322740521Anyplus II Spinal Fixation System3885-75803885-75802025-12-23
08800322740538Anyplus II Spinal Fixation System3885-75853885-75852025-12-23
08800322740545Anyplus II Spinal Fixation System3885-75903885-75902025-12-23
08800322740552Anyplus II Spinal Fixation System3885-75953885-75952025-12-23
08800322740569Anyplus II Spinal Fixation System3885-75003885-75002025-12-23
08800322740576Anyplus II Spinal Fixation System3885-80303885-80302025-12-23
08800322740583Anyplus II Spinal Fixation System3885-80353885-80352025-12-23
08800322740590Anyplus II Spinal Fixation System3885-80403885-80402025-12-23
08800322740606Anyplus II Spinal Fixation System3885-80453885-80452025-12-23
08800322740613Anyplus II Spinal Fixation System3885-80503885-80502025-12-23
08800322740620Anyplus II Spinal Fixation System3885-80553885-80552025-12-23
08800322740637Anyplus II Spinal Fixation System3885-80603885-80602025-12-23
08800322740644Anyplus II Spinal Fixation System3885-80653885-80652025-12-23

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Primary DI, Brand, Company table
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