FDA.reportPublic FDA data

NA

Primary DI
10705034721941
Brand
NA
Company
Synthes GmbH
Model
03.702.751S
Catalog number
03702751S
Device description
CAVITY CREATION INSTRUMENT 15MM-STERILE
Published
2018-10-31
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
OCJspinal channeling instrument, vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCJSpinal Channeling Instrument, VertebroplastyOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034721941PrimaryGS10
H98103702751S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503472194110705034721941

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAOCJ2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAOCJ2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAOCJ2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAOCJ2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAOCJ2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAOCJ2025-12-17
08033860046613BIOPSYBELLBIOPSYBELL SRLOCJ2025-10-27
06923558507569Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.OCJ2025-10-23
06923558509693Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.OCJ2025-10-23
08809281659806TVP System (Vertebra Plasty SET B)Taeyeon Medical co.,Ltd.OCJ2025-09-03
08809281659417PCD SystemTaeyeon Medical co.,Ltd.OCJ2025-08-22
00815212026973BLAZER-C CURVED INJECTION SYSTEM-MVIzi Medical Products, LLCOCJ2025-05-21
B90829211908Main-AXS Needle-RetropsoasMainstream Medical Devices, LLCOCJ2025-04-30
08053175016125Vertebroplasty NeedleADRIA SRLOCJ2025-04-07
B908350008000Main-AXS Needle-Spinal SimplicityMainstream Medical Devices, LLCOCJ2024-12-03
B908350009000Main-AXS Needle-Spinal SimplicityMainstream Medical Devices, LLCOCJ2024-12-03
08800046100380CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-10-29
08800046101080CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-10-29
08800046101202CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-10-29
08058964724687V-AccessG21 SRLOCJ2024-10-16
08058964725356V-AccessG21 SRLOCJ2024-10-16
08058964725363V-AccessG21 SRLOCJ2024-10-16
08058964725417V-AccessG21 SRLOCJ2024-10-16
08058964724021KeyFix Direct Access NeedleG21 SRLOCJ2024-10-10
08058964724052KeyFix Bone Cement Filler CannulaG21 SRLOCJ2024-10-10
08058964724083KeyFix Bone Cement Filler CannulaG21 SRLOCJ2024-10-10
08058964724113KeyFix Direct Access NeedleG21 SRLOCJ2024-10-10
08058964725431V-AccessG21 SRLOCJ2024-10-10
08058964725448V-AccessG21 SRLOCJ2024-10-10
08058964727725Keyfix direct access needle 8GG21 SRLOCJ2024-10-10