FDA.reportPublic FDA data

AccuPort® Cannula

Primary DI
00889024205192
Brand
AccuPort® Cannula
Company
Zimmer Knee Creations, Inc.
Model
308.081
Catalog number
308.081
Published
2016-05-18
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
FGYCannula, Injection
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGYCannula, InjectionGeneral, Plastic Surgery1
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190814000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190814000AccuFill Bone Substitute MaterialZimmer Knee Creations2019-06-10MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024205192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024205192008890242051928890242051920889024205192

GMDN Terms#

Term, Definition table
TermDefinition
Bone grafting cannulaA rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length200Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
484-887-8902KC.Customerservice@zimmerbiomet.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00889024205390SCP614.5822015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017867Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017874Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017881Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017898Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017904Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017911Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017928Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
03760191133723GlassBone GranulesNORAKERMQV2026-05-27
03760191133730GlassBone GranulesNORAKERMQV2026-05-27
03760191133747GlassBone GranulesNORAKERMQV2026-05-27
03760191133754GlassBone GranulesNORAKERMQV2026-05-27
03760191133761GlassBone GranulesNORAKERMQV2026-05-27
03760191133778GlassBone GranulesNORAKERMQV2026-05-27
03760191133785GlassBone GranulesNORAKERMQV2026-05-27
03760191134812AktiBone GranulesNORAKERMQV2026-05-27
03760191134829AktiBone GranulesNORAKERMQV2026-05-27
03760191134836AktiBone GranulesNORAKERMQV2026-05-27
03760191134843AktiBone GranulesNORAKERMQV2026-05-27
03760191134850AktiBone GranulesNORAKERMQV2026-05-27
03760191134867AktiBone GranulesNORAKERMQV2026-05-27
03760191134874AktiBone GranulesNORAKERMQV2026-05-27
03760191134881MectaBlast GranulesNORAKERMQV2026-05-27
03760191134898MectaBlast GranulesNORAKERMQV2026-05-27
03760191134904MectaBlast GranulesNORAKERMQV2026-05-27
03760191134911MectaBlast GranulesNORAKERMQV2026-05-27
03760191134928MectaBlast GranulesNORAKERMQV2026-05-27