FDA.reportPublic FDA data

Legion

Primary DI
00885556770481
Brand
Legion
Company
Smith & Nephew, Inc.
Model
E0016756-2
Catalog number
E0016756-2
Device description
I/M DRILL GUIDE
Published
2019-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113038000SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTSSmith & Nephew, Inc.2012-01-05HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556770481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556770481008855567704818855567704810885556770481

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It 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 at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010482280CLEAR-TRAC721012172101212015-10-22
03596010532619NA721071972107192015-08-30
03596010505132SCULPTOR721069772106972015-08-30
03596010505149SCULPTOR721069672106962015-08-30
03596010505170SCULPTOR721069572106952015-08-30
03596010505194SCULPTOR721070072107002015-08-30
00885554016703560P72202351722023512015-08-29
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810129550023OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550030OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550047OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550061OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550078OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550085OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550108OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550115OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550122OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550139OvertureTiOverture Resurfacing IncHSX2026-10-18
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
05404028000922SurgiCase PlannerMaterialise NVHSX2025-05-14
00822409130153N/AOrtho Development CorporationHSX2025-03-17
00822409130160N/AOrtho Development CorporationHSX2025-03-17
00822409130177N/AOrtho Development CorporationHSX2025-03-17
00822409130184N/AOrtho Development CorporationHSX2025-03-17
00822409130191N/AOrtho Development CorporationHSX2025-03-17
00822409130207N/AOrtho Development CorporationHSX2025-03-17
00822409130214N/AOrtho Development CorporationHSX2025-03-17
00822409130221N/AOrtho Development CorporationHSX2025-03-17
00822409130238N/AOrtho Development CorporationHSX2025-03-17
00822409130245N/AOrtho Development CorporationHSX2025-03-17
00822409130252N/AOrtho Development CorporationHSX2025-03-17
00822409130269N/AOrtho Development CorporationHSX2025-03-17
00810129550221OvertureTiOverture Resurfacing IncHSX2024-12-06
00810129550238OvertureTiOverture Resurfacing IncHSX2024-12-06
00810129550245OvertureTiOverture Resurfacing IncHSX2024-12-06
00810129550016OvertureTiOverture Resurfacing IncHSX2023-10-18
00810129550054OvertureTiOverture Resurfacing IncHSX2023-10-18