FDA.reportPublic FDA data

LCS COMPLETE

Primary DI
10603295224501
Brand
LCS COMPLETE
Company
DEPUY ORTHOPAEDICS, INC.
Model
9505-01-071
Catalog number
950501071
Device description
LCS COMPLETE PATHWAY A/P BLOCK SM+
Published
2015-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10603295224501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329522450110603295224501

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295015154DURALOC1220-28-1481220281482015-09-24
10603295015161DURALOC1220-28-1501220281502015-09-24
10603295015178DURALOC1220-28-1521220281522015-09-24
10603295015185DURALOC1220-28-1541220281542015-09-24
10603295015192DURALOC1220-28-1561220281562015-09-24
10603295015208DURALOC1220-28-1581220281582015-09-24
10603295015215DURALOC1220-28-1601220281602015-09-24
10603295015222DURALOC1220-28-1621220281622015-09-24
10603295015239DURALOC1220-28-1641220281642015-09-24
10603295015246DURALOC1220-28-1661220281662015-09-24
10603295015536DURALOC1220-32-1521220321522015-09-24
10603295015543DURALOC1220-32-1541220321542015-09-24
10603295015550DURALOC1220-32-1561220321562015-09-24
10603295015567DURALOC1220-32-1581220321582015-09-24
10603295015574DURALOC1220-32-1601220321602015-09-24
10603295015581DURALOC1220-32-1621220321622015-09-24
10603295015598DURALOC1220-32-1641220321642015-09-24
10603295015604DURALOC1220-32-1661220321662015-09-24
10603295155010NA2841-10-0002841100002018-09-24
10603295552390ATTUNE2999-66-9712999669712026-05-18

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