FDA.reportPublic FDA data

SCP®

Primary DI
00889024686977
Brand
SCP®
Company
Zimmer Knee Creations, Inc.
Model
664584
Published
2025-07-03
Public version status
New
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
00889024686977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024686977008890246869778890246869770889024686977

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.

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
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
00889024205390SCP614.5822015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS186950Aligned Medical SolutionsAligned Medical SolutionsOJH2026-08-03
10198956372849CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956423824CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956439429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956483613CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956495333CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956497849CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956500150CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956503106CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956503182CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956506824CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956510333CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956510869CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956512504CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956512566CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956516076CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956518728CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956521230CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956521308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956523777CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956523838CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956529601CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956532380CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956533455CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956533462CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956533868CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956534216CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956534445CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956534995CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956535138CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31