FDA.reportPublic FDA data

Ultra Compression Screw System

Primary DI
00810211043839
Brand
Ultra Compression Screw System
Company
Pace Surgical, Inc.
Model
PS2-4000007
Catalog number
PS2-4000007
Device description
Driver, T7
Published
2026-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810211043839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810211043839008102110438398102110438390810211043839

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119302878
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810211040692Ultra Compression Screw SystemPS1-1155038PS1-11550382026-04-28
00810211040005Ultra Compression Screw SystemPS3-1000004PS3-10000042026-04-27
00810211040012Ultra Compression Screw SystemPS3-2000025PS3-20000252026-04-27
00810211040029Ultra Compression Screw SystemPS3-2000030PS3-20000302026-04-27
00810211040036Ultra Compression Screw SystemPS3-2000035PS3-20000352026-04-27
00810211040043Ultra Compression Screw SystemPS3-2000040PS3-20000402026-04-27
00810211040050Ultra Compression Screw SystemPS3-2000055PS3-20000552026-04-27
00810211040067Ultra Compression Screw SystemPS3-2000060PS3-20000602026-04-27
00810211040074Ultra Compression Screw SystemPS1-1130010PS1-11300102026-04-27
00810211040081Ultra Compression Screw SystemPS1-1130011PS1-11300112026-04-27
00810211040098Ultra Compression Screw SystemPS1-1130012PS1-11300122026-04-27
00810211040104Ultra Compression Screw SystemPS1-1130013PS1-11300132026-04-27
00810211040111Ultra Compression Screw SystemPS1-1130014PS1-11300142026-04-27
00810211040128Ultra Compression Screw SystemPS1-1130015PS1-11300152026-04-27
00810211040135Ultra Compression Screw SystemPS1-1130016PS1-11300162026-04-27
00810211040142Ultra Compression Screw SystemPS1-1130017PS1-11300172026-04-27
00810211040159Ultra Compression Screw SystemPS1-1130018PS1-11300182026-04-27
00810211040166Ultra Compression Screw SystemPS1-1130019PS1-11300192026-04-27
00810211040173Ultra Compression Screw SystemPS1-1130020PS1-11300202026-04-27
00810211040180Ultra Compression Screw SystemPS1-1130022PS1-11300222026-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118154644LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154651LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154668LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154675LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154682LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154699LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154705LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154712LEVEL ONEKLS-Martin L.P.HXX2026-07-21
00199150072323Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-19
00199150081875Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-19
07290019361336OSSIO® InserterOSSIO LTDHXX2026-07-19
00763000913267Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-17
18257200051304REMOVAL INSTRUMENTSOrthofix US LLCHXX2026-07-17
18257200051311REMOVAL INSTRUMENTSOrthofix US LLCHXX2026-07-17
18257200051410PROVIEWOrthofix US LLCHXX2026-07-17
18257200051427REMOVAL INSTRUMENTSOrthofix US LLCHXX2026-07-17
18257200131181Firebird SI FusionOrthofix US LLCHXX2026-07-17
18257200136285Firebird SI FusionOrthofix US LLCHXX2026-07-17
18257200142620Firebird SI FusionOrthofix US LLCHXX2026-07-17
18257200163724PILLAR SA TiOrthofix US LLCHXX2026-07-17
18257200163731PILLAR SA TiOrthofix US LLCHXX2026-07-17
18257200163830PILLAR SA TiOrthofix US LLCHXX2026-07-17
18257200163847PILLAR SA TiOrthofix US LLCHXX2026-07-17
00199150081882Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-10
00199150081899Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-10
00842188132513Tools - ScrewsTrimed, INC.HXX2026-07-09
00842188132520Tools - ScrewsTrimed, INC.HXX2026-07-09
06974940307878endophixSuzhou Endophix Co., Ltd.HXX2026-06-23
008401944961003P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944963773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10