FDA.reportPublic FDA data

Ultra Compression Screw System

Primary DI
00810211044065
Brand
Ultra Compression Screw System
Company
Pace Surgical, Inc.
Model
PS2-2200020
Catalog number
PS2-2200020
Device description
Drill Guide, 2.0mm
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
00810211044065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810211044065008102110440658102110440650810211044065

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. 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
00190776423896MillenniumAvalign Technologies, Inc.FZX2026-08-26
10886982362988NASynthes GmbHFZX2026-08-26
10886982362995NASynthes GmbHFZX2026-08-26
10886982363008NASynthes GmbHFZX2026-08-26
10886982363015NASynthes GmbHFZX2026-08-26
008890247114712.9 JuggerKnot Self-Punching ObturatorZimmer, Inc.FZX2026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaZimmer, Inc.FZX2026-08-25
00889024712294Pin Target AssemblyZimmer, Inc.FZX2026-08-25
06937278653598CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653604CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653611CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653628CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654250CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654267CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654281CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654304CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654748CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654755CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654762CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654779CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654786CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654823CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654830CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654847CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654854CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654861CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654878CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654885CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654892CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654908CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22