FDA.reportPublic FDA data

RejuvaKnee

Primary DI
00813954026039
Brand
RejuvaKnee
Company
COLLAGEN MATRIX, INC.
Model
REJ090
Catalog number
REJ090
Device description
Collagen Meniscus Implant
Published
2024-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
00813954026039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954026039008139540260398139540260390813954026039

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
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(201) 405-1477contact@regenity.com

Regulatory Flags#

DUNS number
176262442
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10813954024261OsteoMaxx PlugXA6252021-07-26
10813954024278OsteoMaxx PlugXA1202021-07-26
00813954020433Zimmer Collagen Tape0100Z2015-10-23
00813954020440Zimmer Collagen Patch0101Z2015-10-23
00813954020457Zimmer Collagen Plug0102Z2015-10-23
00813954029078PLENA FLEXCDMPP3040CDMPP30402026-10-13
00813954029085PLENA MEDIUMPDM3040PDM30402026-10-13
00813954021065AugmatrixM600-020-102015-10-23
00813954021072AugmatrixM600-040-102015-10-23
00813954021089AugmatrixM610-050-102015-10-23
00813954021096AugmatrixM610-100-102015-10-23
00813954021102AugmatrixM630-100-102015-10-23
00813954021119AugmatrixM630-200-102015-10-23
00813954021126AugmatrixM620-020-102015-10-23
00813954021133AugmatrixM620-050-102015-10-23
00813954021140AugmatrixM620-100-102015-10-23
00813954021157AugmatrixM640-120-102015-10-23
00813954028798Dyna-Bone Plug10.905.062510.905.06252026-07-02
00813954028804Dyna-Bone Plug10.905.102010.905.10202026-07-02
M440SGG0500StarGraft GranulesSGG0502015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954026022RejuvaKneeCOLLAGEN MATRIX, INC.OLC2024-11-04
M92843021Collagen Meniscus Implant CMI®IVY SPORTS MEDICINE LLCOLC2017-08-14
M92843001Collagen Meniscus Implant CMI®IVY SPORTS MEDICINE LLCOLC2015-10-24
M92843011Collagen Meniscus Implant CMI®IVY SPORTS MEDICINE LLCOLC2015-10-24