FDA.reportPublic FDA data

SIGMA

Primary DI
10603295228745
Brand
SIGMA
Company
DEPUY ORTHOPAEDICS, INC.
Model
9505-02-175
Catalog number
950502175
Device description
SIGMA HIGH PERFORMANCE RP-F CLASSIC AP CHAMFER BLOCK 1
Published
2015-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTZINSTRUMENT, CUTTING, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295228745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329522874510603295228745

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
080506581
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295562108VELYS Hip Navigation4515801514515801512026-03-24
10603295553625ATTUNE2999-67-0322999670322026-02-17
10603295553632ATTUNE2999-67-0332999670332026-02-17
10603295553649ATTUNE2999-67-0342999670342026-02-17
10603295553656ATTUNE2999-67-0352999670352026-02-17
10603295554974EMPHASYS2999-67-0462999670462026-02-04
10603295080121AML EXCEL2001-65-0002001650002018-06-15
10603295082408DURALOC2015-24-0002015240002018-09-24
10603295083382SIGMA2024-57-1112024571112018-09-24
10603295084075SIGMA2024-85-0052024850052018-09-24
10603295088042GLOBAL FX2128-01-0222128010222018-09-24
10603295090540GLOBAL AP2130-01-0552130010552018-09-24
10603295090687GLOBAL AP2130-04-0002130040002018-09-24
10603295094005NA2178-30-1222178301222018-09-24
10603295095651LCS COMPLETION2178-60-0282178600282018-09-24
10603295096184NA2178-63-1242178631242018-09-24
10603295096191NA2178-63-1262178631262018-09-24
10603295098935PINNACLE2217-50-0042217500042018-09-24
10603295098942PINNACLE2217-50-0052217500052018-09-24
10603295098959PINNACLE2217-50-0062217500062018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810212930497SURGIPROSSurgipros, LLCHTZ2026-05-22
10603295553625ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553632ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553649ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553656ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
00190376538945Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376538952Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376700885Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376700892Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00840180544709General InstrumentsALPHATEC SPINE, INC.HTZ2026-01-29
00840180544716General InstrumentsALPHATEC SPINE, INC.HTZ2026-01-29
00840180544662General InstrumentsALPHATEC SPINE, INC.HTZ2025-12-31
10603295553663ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553670ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553687ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553694ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553700ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295554929ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
00196449033638Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-10
00196449033669Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-10
00196449033683Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-10
00196449033423Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033430Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033447Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033478Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033485Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033492Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033584Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033607Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033621Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02