FDA.reportPublic FDA data

AnyPlus® Cervical PEEK Cage System

Primary DI
08809695610400
Brand
AnyPlus® Cervical PEEK Cage System
Company
GS Medical Co., Ltd.
Model
GS138-8303
Catalog number
GS138-8303
Device description
Rongure 4mm, Up-Angle
Published
2025-03-17
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
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809695610400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809695610400088096956104008809695610400

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. 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
true
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
08800322709924VEGA Cervical Screw SystemGTI0108-0003GTI0108-00032026-09-22
08800322709993VEGA Cervical Screw SystemGS128-1600GS128-16002026-09-22
08800322719015VEGA Cervical Screw SystemGS128-0700GS128-07002026-09-22
08800322719022VEGA Cervical Screw SystemGS128-1730GS128-17302026-09-22
08800322759639VEGA Cervical Screw SystemGS128-1010GS128-10102026-09-22
08800322759646VEGA Cervical Screw SystemGS128-1011GS128-10112026-09-22
08800322759653VEGA Cervical Screw SystemGS128-1012GS128-10122026-09-22
08800322759660VEGA Cervical Screw SystemGS128-1013GS128-10132026-09-22
08800322759677VEGA Cervical Screw SystemGS128-1014GS128-10142026-09-22
08800322759684VEGA Cervical Screw SystemGS128-1560GS128-15602026-09-22
08800322759691VEGA Cervical Screw SystemGS128-9000GS128-90002026-09-22
08800322759707VEGA Cervical Screw SystemGS128-9100GS128-91002026-09-22
08800322759714VEGA Cervical Screw SystemGS128-9110GS128-91102026-09-22
08809885759667VEGA Cervical Screw SystemGS128-9011GS128-90112026-09-22
08809885759674VEGA Cervical Screw SystemGS128-9012GS128-90122026-09-22
08809885759797VEGA Cervical Screw SystemGS128-9015GS128-90152026-09-22
08809974779408VEGA Cervical Screw SystemGS128-0200GS128-02002026-09-22
08809974779415VEGA Cervical Screw SystemGS128-0300GS128-03002026-09-22
08809974779422VEGA Cervical Screw SystemGS128-0310GS128-03102026-09-22
08809974779439VEGA Cervical Screw SystemGS128-0320GS128-03202026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267902Snowden-PencerSTERIS Deutschland GmbHHTX2026-09-25
00724995274597V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321390V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321406V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321413V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321420V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00190776431105MillenniumAvalign Technologies, Inc.HTX2026-09-21
00190776427955MillenniumAvalign Technologies, Inc.HTX2026-08-27
00190776427962MillenniumAvalign Technologies, Inc.HTX2026-08-27
00192896122048Ceramitec Universal Klick Ferris Smith Rongeur ShaftSONTEC INSTRUMENTS, INC.HTX2026-08-25
B382SD9227656000Surgical DirectSurgical Direct, Inc.HTX2026-08-21
00190776426682MillenniumAvalign Technologies, Inc.HTX2026-08-19
00190776426699MillenniumAvalign Technologies, Inc.HTX2026-08-19
B382SD922812030Surgical DirectSurgical Direct, Inc.HTX2026-08-07
00190776422912MillenniumAvalign Technologies, Inc.HTX2026-08-03
00190776422929MillenniumAvalign Technologies, Inc.HTX2026-08-03
B382SD4319D0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD480007LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD480046220Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482030LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482047PH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482058LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482505LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482506LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD4829130Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD4882030Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD488603SLH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
00190776422455MillenniumAvalign Technologies, Inc.HTX2026-07-31
B382SD1450500050Surgical DirectSurgical Direct, Inc.HTX2026-07-31
B382SD914848050Surgical DirectSurgical Direct, Inc.HTX2026-07-28