FDA.reportPublic FDA data

Ultra Compression Screw System

Primary DI
00810211044140
Brand
Ultra Compression Screw System
Company
Pace Surgical, Inc.
Model
PS2-2400044
Catalog number
PS2-2400044
Device description
K-wire Guide, 4.4mm
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810211044140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810211044140008102110441408102110441400810211044140

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, reusableA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. 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
008100978037493.0mm GUIDE WIRE 355mmOsteocentric Technologies, Inc.FZX2026-06-02
00889024707382Persona Tensor Sizer Arm – LongZimmer, Inc.FZX2026-05-29
00889024707399Persona Tensor Sizer Arm – StdZimmer, Inc.FZX2026-05-29
00889024707405Persona Tensor Sizer BodyZimmer, Inc.FZX2026-05-29
G079INL1160070Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
G079INL1160120Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
08806373887772BENCOX Surgical InstrumentsCorentec Co., LtdFZX2026-01-12
08800089479375Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2025-12-04
07640332475348CURE 2.0 ACPSpineArt SAFZX2025-11-12
07640375235732PERLA ® TL MISSpineArt SAFZX2025-11-10
G79153202001620G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
G79153202021615G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
08800071017462Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017479Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017486Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017493Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017509Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017516Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017523Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084389Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084396Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084402Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084419Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084426Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084433Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
G463090799PK0Spine InstrumentsBOXSPINE HOLDINGS, INC.FZX2025-01-16
008101182101673.7mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101744.2mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101815.5mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
08800089436033Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17