FDA.reportPublic FDA data

Legion

Primary DI
00885556630389
Brand
Legion
Company
Smith & Nephew, Inc.
Model
E0014828-6
Catalog number
E0014828-6
Device description
RIGHT MEDIAL PLUS FIN PUNCH SIZE 3-4
Published
2016-01-16
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
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121393000SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2012-08-07MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556630389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556630389008855566303898855566303890885556630389

GMDN Terms#

Term, Definition table
TermDefinition
Bone punch, reusableA hand-held manual surgical instrument with a cutting/biting action used to cut small cross-sectional pieces of bone typically for biopsy or fixation procedures during a surgical intervention. It is typically designed with a long, thin, two-part sliding shaft (the upper part sliding along the lower part) which is joined to sprung (self-opening), pivoted, pistol grip handles. The working end terminates with a sharp, angled, cutting jaw that closes over an endpiece when the handles are squeezed together cutting through the bone. It is available in various sizes and designs (e.g., it can have upward or downward located jaws) and is made of high-grade stainless steel. 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
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348215158828World Knee MC Poly Insert - Size 8 - 10mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158835World Knee MC Poly Insert - Size 8 - 11mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158842World Knee MC Poly Insert - Size 8 - 12mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158859World Knee MC Poly Insert - Size 8 - 13mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158866World Knee MC Poly Insert - Size 8 - 14mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158873World Knee MC Poly Insert - Size 8 - 15mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158880World Knee MC Poly Insert - Size 8 - 16mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158897World Knee MC Poly Insert - Size 8 - 17mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158903World Knee MC Poly Insert - Size 8 - 18mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158910World Knee MC Poly Insert - Size 8 - 10mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158927World Knee MC Poly Insert - Size 8 - 11mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158934World Knee MC Poly Insert - Size 8 - 12mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158941World Knee MC Poly Insert - Size 8 - 13mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158958World Knee MC Poly Insert - Size 8 - 14mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158965World Knee MC Poly Insert - Size 8 - 15mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158972World Knee MC Poly Insert - Size 8 - 16mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158989World Knee MC Poly Insert - Size 8 - 17mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158996World Knee MC Poly Insert - Size 8 - 18mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160265World Knee MC Vit-E Poly Insert - Size 7 - 10mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160272World Knee MC Vit-E Poly Insert - Size 7 - 11mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160289World Knee MC Vit-E Poly Insert - Size 7 - 12mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160296World Knee MC Vit-E Poly Insert - Size 7 - 13mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160302World Knee MC Vit-E Poly Insert - Size 7 - 14mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160319World Knee MC Vit-E Poly Insert - Size 7 - 15mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160326World Knee MC Vit-E Poly Insert - Size 7 - 16mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160333World Knee MC Vit-E Poly Insert - Size 7 - 17mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160340World Knee MC Vit-E Poly Insert - Size 7 - 18mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160357World Knee MC Vit-E Poly Insert - Size 7 - 10mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160364World Knee MC Vit-E Poly Insert - Size 7 - 11mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160371World Knee MC Vit-E Poly Insert - Size 7 - 12mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09