FDA.reportPublic FDA data

GSO ACP1 Anterior Cervical Plate System

Primary DI
M9935093650
Brand
GSO ACP1 Anterior Cervical Plate System
Company
UNIFIED SPINE, LLC
Model
509365
Device description
3 Level Plate
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9935093650PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118413370
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9935042050GSO GS1 Spinal System5042052018-09-21
M9935042180GSO GS1 Spinal System5042182018-09-21
M9935042190GSO GS1 Spinal System5042192018-09-21
M9935071650GSO PCT Spinal System5071652018-09-21
M9935071760GSO PCT Spinal System5071762018-09-21
M9935071770GSO PCT Spinal System5071772018-09-21
M9935091200GSO ACP1 Anterior Cervical Plate System5091202016-09-14
M9935091220GSO ACP1 Anterior Cervical Plate System5091222016-09-14
M9935091240GSO ACP1 Anterior Cervical Plate System5091242016-09-14
M9935091260GSO ACP1 Anterior Cervical Plate System5091262016-09-14
M9935091280GSO ACP1 Anterior Cervical Plate System5091282016-09-14
M9935091300GSO ACP1 Anterior Cervical Plate System5091302016-09-15
M9935091320GSO ACP1 Anterior Cervical Plate System5091322016-09-14
M9935092340GSO ACP1 Anterior Cervical Plate System5092342016-09-15
M9935092370GSO ACP1 Anterior Cervical Plate System5092372016-09-15
M9935092400GSO ACP1 Anterior Cervical Plate System5092402016-09-15
M9935092430GSO ACP1 Anterior Cervical Plate System5092432016-09-15
M9935092460GSO ACP1 Anterior Cervical Plate System5092462016-09-15
M9935092490GSO ACP1 Anterior Cervical Plate System5092492016-09-15
M9935092520GSO ACP1 Anterior Cervical Plate System5092522016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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