FDA.reportPublic FDA data

RejuvaKnee

Primary DI
00813954026022
Brand
RejuvaKnee
Company
COLLAGEN MATRIX, INC.
Model
REJ075
Catalog number
REJ075
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
00813954026022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954026022008139540260228139540260220813954026022

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
00813954028767Gibson Healthcare Alloplast6247-9926247-9922026-05-26
00813954028774Gibson Healthcare Alloplast6248-0086248-0082026-05-26
00813954028781Gibson Healthcare Alloplast6248-0176248-0172026-05-26
00813954028873PuraKOTE+PGKTE+PGKTE+2026-05-26
00813954028880PuraPLUG+PGPLG+PGPLG+2026-05-26
00813954028897PuraTAPE+PGTPE+PGTPE+2026-05-26
00813954028385collatene509101050910102026-05-05
00813954028620AmpliDermAMPLIDERM-ROUND-10AMPLIDERM-ROUND-102026-04-06
00813954028637AmpliDermAMPLIDERM-THICK-15X20AMPLIDERM-THICK-15X202026-04-06
00813954028644AmpliDermAMPLIDERM-THICK-20X30AMPLIDERM-THICK-20X302026-04-06
00813954028651AmpliDermAMPLIDERM-THICK-30X40AMPLIDERM-THICK-30X402026-04-06
00813954028668AmpliDermAMPLIDERM-THIN-15X20AMPLIDERM-THIN-15X202026-04-06
00813954028675AmpliDermAMPLIDERM-THIN-20X30AMPLIDERM-THIN-20X302026-04-06
00813954028682AmpliDermAMPLIDERM-THIN-30X40AMPLIDERM-THIN-30X402026-04-06
00813954028590bioMAINTAINOUSA1EUOUSA1EU2026-03-23
00813954028606bioMAINTAINOUSA2EUOUSA2EU2026-03-23
00813954028613bioMAINTAINOUSA3EUOUSA3EU2026-03-23
00813954028736SALVIN OraCOTE+ORACOTE-PLUS-PKG-10ORACOTE-PLUS-PKG-102026-03-18
00813954028743SALVIN OraPLUG+ORAPLUG-PLUS-PKG-10ORAPLUG-PLUS-PKG-102026-03-18
00813954028750SALVIN OraTAPE+ORATAPE-PLUS-PKG-10ORATAPE-PLUS-PKG-102026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954026039RejuvaKneeCOLLAGEN 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