PyroCarbon Lunate

Primary DI
00885556858752
Brand
PyroCarbon Lunate
Company
Smith & Nephew, Inc.
Model
LUN-710-04-WW
Catalog number
LUN-710-04-WW
Device description
LUNATE SZ. 04
Published
2023-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWNProsthesis, wrist, carpal lunate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWNProsthesis, Wrist, Carpal LunateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080997000ASCENSION PYROCARBON LUNATEAscension Orthopedics, Inc.2008-06-17KWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556858752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556858752008855568587528855568587520885556858752

GMDN Terms#

Term, Definition table
TermDefinition
Carpal lunate prosthesisA sterile implantable device designed to replace the lunate bone in the proximal carpal row of the wrist typically in the presence of avascular necrosis, localized osteoarthritic changes, or longstanding dislocations. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal), that may reflect the shape of the native bone. Short-term fixation is typically performed with sutures.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010469182GENESIS II71421012714210122015-08-30
03596010469212GENESIS II71421015714210152015-08-30
03596010469229GENESIS II71421016714210162015-08-30
03596010469236GENESIS II71421017714210172015-08-30
03596010469267GENESIS II71421112714211122015-08-30
03596010469274GENESIS II71421113714211132015-08-30
03596010469281GENESIS II71421114714211142015-08-30
03596010469298GENESIS II71421115714211152015-08-30
03596010469304GENESIS II71421116714211162015-08-30
03596010469328GENESIS II71421118714211182015-08-30
03596010531018JOURNEY74024629740246292015-08-29
03596010531025JOURNEY74024632740246322015-08-29
03596010554468JOURNEY74024623740246232015-08-29
03596010554475JOURNEY74024626740246262015-08-29
03596010554512JOURNEY74024826740248262015-08-29
03596010554529JOURNEY74024829740248292015-08-29
03596010554536JOURNEY74024832740248322015-08-29
03596010000675OXINIUM71343603713436032015-08-30
03596010469199GENESIS II71421013714210132015-08-30
03596010469205GENESIS II71421014714210142015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556858721PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858738PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858745PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858769PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858820PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858837PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858844PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858851PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858868PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
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M5288W123517W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W152217W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W152223W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W153517W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W153523W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W950016W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W122217A0HemiCAPITATETMARTHROSURFACE INCORPORATEDKWN2018-04-16
00887868239830Maestro™ Total WristBiomet Orthopedics, LLCKWN2018-03-02
00887868239847Maestro™ Total WristBiomet Orthopedics, LLCKWN2018-03-02
00887868239854Maestro™ Total WristBiomet Orthopedics, LLCKWN2018-03-02
10381780116240Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116257Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116264Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116271Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116288Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780235040Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236795Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236801Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236818Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236825Integra®Ascension Orthopedics, Inc.KWN2016-08-15