FDA.reportPublic FDA data

Ultra Compression Screw System

Primary DI
00810211043891
Brand
Ultra Compression Screw System
Company
Pace Surgical, Inc.
Model
PS2-2100041
Catalog number
PS2-2100041
Device description
Overdrill, 4.1mm
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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810211043891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810211043891008102110438918102110438910810211043891

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusable"A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a ""twist drill"", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. 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
18059015378306Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
18059015378313Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
B803SYN31005100ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310230ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310650ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310660ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310670ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310680ORTHOMEDORTHO-MED, INC.HTW2026-07-22
00190776403270MillenniumAvalign Technologies, Inc.HTW2026-07-21
08059386748688Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2026-07-21
B504OM19S17050BrasselerProvisionHTW2026-07-20
B504OM3162880SynthesProvisionHTW2026-07-20
B504OM4058830BiometProvisionHTW2026-07-20
B504OM4058890BiometProvisionHTW2026-07-20
B504OM542022S0StrykerProvisionHTW2026-07-20
B504OM7024470StrykerProvisionHTW2026-07-20
B504OMA37330MedartisProvisionHTW2026-07-20
B504OMAR1214L0ArthrexProvisionHTW2026-07-20
B504OMAR1217L0ArthrexProvisionHTW2026-07-20
B504OMCSS07247SQ0WrightProvisionHTW2026-07-20
B504OMKM166310260BrasselerProvisionHTW2026-07-20
B504OMKM166310680BrasselerProvisionHTW2026-07-20
00190776400552MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400576MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400644MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402075MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402082MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402204MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400293MillenniumAvalign Technologies, Inc.HTW2026-07-17
18257200076536CETRAOrthofix US LLCHTW2026-07-17