FDA.reportPublic FDA data

Ultra Compression Screw System

Primary DI
00810211043907
Brand
Ultra Compression Screw System
Company
Pace Surgical, Inc.
Model
PS2-2500034
Catalog number
PS2-2500034
Device description
Drill, 3.4mm
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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810211043907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810211043907008102110439078102110439070810211043907

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606191791Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
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00840606191814Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191821Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191852Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195768Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195775Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00190376544397InvictusALPHATEC SPINE, INC.HTW2026-07-30
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00190376544427InvictusALPHATEC SPINE, INC.HTW2026-07-30
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00190376544472InvictusALPHATEC SPINE, INC.HTW2026-07-30
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