FDA.reportPublic FDA data

ORTHOMATCH

Primary DI
00885556726150
Brand
ORTHOMATCH
Company
Smith & Nephew, Inc.
Model
71442408
Catalog number
71442408
Device description
METAL TRIAL LUG PUNCH
Published
2019-08-23
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
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170648000ANTHEM CR Total Knee SystemSmith & Nephew, Inc.2017-05-11JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556726150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556726150008855567261508855567261500885556726150

GMDN Terms#

Term, Definition table
TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. It is and is available in various cutting head sizes, and is not primarily intended for soft-tissue coring. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20
TKRL00020IBI0PointCloud Knee InstrumentsUnik Orthopedics Inc.JWH2026-10-20