FDA.reportPublic FDA data

Collagen Meniscus Implant CMI®

Primary DI
M92843001
Brand
Collagen Meniscus Implant CMI®
Company
IVY SPORTS MEDICINE LLC
Model
Medial 7.5 mm
Catalog number
4300
Published
2015-10-24
Public version status
Update
Distribution status
Not 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
OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine CollagenGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M92843001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Meniscus biomatrix implant, animal-derivedA bioabsorbable animal-derived material intended to be implanted to fill a defect in a damaged meniscus for the reinforcement of the remaining meniscus, and to provide a porous scaffold (matrix) intended to be replaced by natural tissue. It is made of an animal-derived material (e.g., bovine or porcine collagen) and is implanted during a minimally-invasive arthroscopic surgical procedure after trimming to fit the measured defect; it is available in a variety of sizes. This device is not intended to replace the entire meniscus.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-624-4422endocustomersupport@stryker.com

Regulatory Flags#

DUNS number
046226406
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M92847011SharpShooter® Surgical Suture470147012015-10-24
M928HS47041SharpShooter® Surgical SutureHS4704HS47042015-10-24
M92843011Collagen Meniscus Implant CMI®Medial 9.0 mm43012015-10-24
M92843021Collagen Meniscus Implant CMI®Medial XL43022017-08-14
M92847012SharpShooter® Surgical Suture470147012015-10-24
M92847201Stryker AIR™472047202017-01-13
M92847301IvyAIR Meniscus System, Curved473047302016-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954026022RejuvaKneeCOLLAGEN MATRIX, INC.OLC2024-11-04
00813954026039RejuvaKneeCOLLAGEN MATRIX, INC.OLC2024-11-04
M92843021Collagen Meniscus Implant CMI®IVY SPORTS MEDICINE LLCOLC2017-08-14
M92843011Collagen Meniscus Implant CMI®IVY SPORTS MEDICINE LLCOLC2015-10-24