FDA.reportPublic FDA data

SCP® PF Knee Kit

Primary DI
00889024501287
Brand
SCP® PF Knee Kit
Company
Zimmer Knee Creations, Inc.
Model
464502
Catalog number
464502
Published
2020-06-09
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
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024501287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024501287008890245012878890245012870889024501287

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft delivery kitA collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)727-5818KC.CustomerService@zimmerbiomet.com

Regulatory Flags#

DUNS number
078836317
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024205192AccuPort® Cannula 308.081308.0812016-05-18
00889024205208AccuPort® Cannula 308.082308.0822016-05-18
00889024686915SCP®4643022025-07-03
00889024686922SCP®4643032025-07-03
00889024686939SCP®4645022025-07-03
00889024686946SCP®4645032025-07-03
00889024686953SCP®5141532025-07-03
00889024686960SCP®6643412025-07-03
00889024686977SCP®6645842025-07-03
00889024205253SCP402.2012015-10-23
00889024205260Subchondroplasty® Knee Kit402.2022015-10-23
00889024205277Subchondroplasty® Knee Kit402.2032015-10-23
00889024205314SCP® Knee Kit414.5022015-10-23
00889024205321SCP® Knee Kit414.5032015-10-23
00889024205338SCP® Foot & Ankle Kit514.3022015-10-23
00889024205345SCP® Foot & Ankle Kit514.3032015-10-23
00889024205352SCP® Foot & Ankle Kit514.3152015-10-23
00889024205369SCP® Foot & Ankle Kit514.5022015-10-23
00889024205376SCP® Foot & Ankle Kit514.5032015-10-23
00889024205383SCP614.5812015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956537798CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956539914CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956545182CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956549050CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956563223CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956276437CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956301719CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956333611CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956361041CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956384439CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956388376CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956519541CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956530782CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956540958CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956544086CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956550063CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956552104CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956552531CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956556478CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956556591CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956557079CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956564145CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956567405CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956567672CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956567931CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956569294CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956570061CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956570078CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956573567CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956574571CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12