FDA.reportPublic FDA data

ACM

Primary DI
04546540055392
Brand
ACM
Company
STRYKER CORPORATION
Model
0306553000
Catalog number
0306-553-000
Device description
Bowl and Cement Cartridge
Published
2018-09-24
Public version status
Update
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
OARInjector, vertebroplasty (does not contain cement)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34546540055393PackageGS16In Commercial Distribution
04546540055392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654005539334546540055393
04546540055392045465400553924546540055392

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement preparation/delivery kitA collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight180Gram

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540466242NA04072500000407-250-0002016-09-23
04546540500229NA04072810000407-281-0002016-09-23
04546540531827NA04072510000407-251-0002016-09-23
04546540144164NA02100100000210-010-0002015-09-24
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033737113813ADRIA srl - KIT OF 2 CEMENT INJECTION CANNULASADRIA SRLOAR2026-08-25
00884450587713StabiliT®Merit Medical Systems, Inc.OAR2026-07-30
08058964729163KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16 GG21 SRLOAR2026-05-05
03701505801211DynamoTEKNIMEDOAR2026-02-02
03701505801228DynamoTEKNIMEDOAR2026-02-02
03701505801235DynamoTEKNIMEDOAR2026-02-02
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAOAR2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAOAR2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAOAR2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAOAR2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAOAR2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAOAR2025-12-17
06923558507569Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.OAR2025-10-23
06923558509693Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.OAR2025-10-23
08053175003439Vertebroplasty Injector KitADRIA SRLOAR2025-04-07
08053175004382Cement Injection CannulaADRIA SRLOAR2025-04-07
03701505801020PureKit Syringe 1.5cc MVTEKNIMEDOAR2025-03-31
03701505801037META+ System 1.5cc MVTEKNIMEDOAR2025-03-31
03701505801075PUREKIT SyringesTEKNIMEDOAR2025-03-31
03701505801082Syringes 4ccTEKNIMEDOAR2025-03-31
03701505801099Syringes 1.5ccTEKNIMEDOAR2025-03-31
03701505800498PureKit Syringe 4cc MVTEKNIMEDOAR2025-03-31
00884450837542StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-12-20
10884450837549StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-12-20
00884450833964DiamondTOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-11-16
10884450833961DiamondTOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-11-16
00815212026935Duro-Ject Bone Cement Injection TubeIzi Medical Products, LLCOAR2024-10-14
08058964724960VHP GUNG21 SRLOAR2024-10-14
08033860022396BIOPSYBELLBIOPSYBELL SRLOAR2024-02-23
08033860022693BIOPSYBELLBIOPSYBELL SRLOAR2024-02-23