FDA.reportPublic FDA data

ASPIRON S ACP SYSTEM

Primary DI
08800247357989
Brand
ASPIRON S ACP SYSTEM
Company
CG MedTech Co.,Ltd.
Model
FCA1019
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220147000Aspiron S ACP SystemU&I Corporation2022-02-16KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800247357989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800247357989088002473579898800247357989

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Regulatory Flags#

DUNS number
688811082
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800308479131ANAX OCT SPINAL SYSTEMOSS07702026-10-14
08800037575166ANAX™ 5.5 SPINAL SYSTEMSF09612026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMSF09622026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMSF09632026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMSF09602026-09-04
08800308479070ANAX™ 5.5 CT SPINAL SYSTEMCTS02202026-08-19
08800308479094ANAX™ 5.5 CT SPINAL SYSTEMCTS02402026-08-19
08800308479117ANAX™ 5.5 CT SPINAL SYSTEMCTS02602026-08-19
08800247359822UniSpace® TPLIF CageTU02902026-06-27
08800247359839UniSpace® TPLIF CageTU03002026-06-27
08800247359846UniSpace® TPLIF CageTU03102026-06-27
08800247359853UniSpace® TPLIF CageTU03202026-06-27
08800247359860UniSpace® TPLIF CageTU03302026-06-27
08800247359877UniSpace® TPLIF CageTU03402026-06-27
08800247359884UniSpace® TPLIF CageTU03502026-06-27
08800247359891UniSpace® TPLIF CageTU01702026-06-27
08800247359907UniSpace® TPLIF CageTU01802026-06-27
08800247359914UniSpace® TPLIF CageTU01902026-06-27
08800247359921UniSpace® TPLIF CageTU02002026-06-27
08800247359938UniSpace® TPLIF CageTU02102026-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916191SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°)ELEVATION SPINE, INC.KWQ2026-10-27
00810017913763Saber-C Body (PT), 14x15x5 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913961Saber-C Body (PT), 14x17x7 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913978Saber-C Body (PT), 14x17x8 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913985Saber-C Body (PT), 14x17x9 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913992Saber-C Body (PT), 14x17x10 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914005Saber-C Body (PT), 15x18x5 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914012Saber-C Body (PT), 15x18x6 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914029Saber-C Body (PT), 15x18x7 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914036Saber-C Body (PT), 15x18x8 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914043Saber-C Body (PT), 15x18x9 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914050Saber-C Body (PT), 15x18x10 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914425Saber-C Body (PT), 14x15x6 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914432Saber-C Body (PT), 14x15x7 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914449Saber-C Body (PT), 14x15x8 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914456Saber-C Body (PT), 14x15x9 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914463Saber-C Body (PT), 14x15x10 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914654Saber-C Body (PT), 15x18x5 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-25