FDA.reportPublic FDA data

OSSEOFIX +

Primary DI
03760177047044
Brand
OSSEOFIX +
Company
TEKNIMED
Model
PRECISION PACK
Catalog number
21302
Published
2020-10-07
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

Product Codes#

Code, Name table
CodeName
JDZMixer, Cement, For Clinical Use
OARInjector, Vertebroplasty (Does Not Contain Cement)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDZMixer, Cement, For Clinical UseOrthopedic1
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760177047044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760177047044037601770470443760177047044

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
764746723
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701505801204DynamoSpinal Cement – MV11-59202026-02-02
03701505801211Dynamo Spinal Cement System Syringe MV 1.5cc11-59212026-02-02
03701505801228DynamoSpinal Cement System Syringe MV 4cc11-59222026-02-02
03701505801235DynamoSpinal Cement System Gun MV11-59232026-02-02
03760177044326Signature -x Cement SVP/N191-14-40002026-01-23
03760177044333Signature -x Cement LVP/N191-14-40012026-01-23
03760177044340Signature -x Cement MVMVP/N191-14-40022026-01-23
03760177040090GENTAFIX1T040140G2025-09-02
03760177040137GENTAFIX3T040340G2025-09-02
03760177043176GENTAFIX3 MVT040341G2025-09-02
03760177042698Euroscrew NGØ6 L20T720620NG2023-12-18
03760177042704Euroscrew NGØ7 L24T720724NG2023-12-18
03760177042711Euroscrew NGØ7 L30T720730NG2023-12-18
03760177042728Euroscrew NGØ8 L24T720824NG2023-12-18
03760177042735Euroscrew NGØ9 L24T720924NG2023-12-18
03760177042742Euroscrew NGØ8 L30T720830NG2023-12-18
03760177042759Euroscrew NGØ9 L30T720930NG2023-12-18
03760177042766Euroscrew NGØ10 L30T721030NG2023-12-18
03760177042773Euroscrew NGØ11 L35T721135NG2023-12-18
03760177042780Euroscrew TCP NGØ06 L20T730620NG2023-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033737113813ADRIA srl - KIT OF 2 CEMENT INJECTION CANNULASADRIA SRLOAR2026-08-25
00840456203163JMUJMU DENTAL, INCJDZ2026-08-18
00840456207123JMUJMU DENTAL, INCJDZ2026-08-18
00840456207130JMUJMU DENTAL, INCJDZ2026-08-18
00840456223628JMUJMU DENTAL, INCJDZ2026-08-18
00840456223635JMUJMU DENTAL, INCJDZ2026-08-18
00840456223642JMUJMU DENTAL, INCJDZ2026-08-18
00840456223659JMUJMU DENTAL, INCJDZ2026-08-18
00840456223789JMUJMU DENTAL, INCJDZ2026-08-18
00840456223796JMUJMU DENTAL, INCJDZ2026-08-18
00840456223802JMUJMU DENTAL, INCJDZ2026-08-18
00884450587713StabiliT®Merit Medical Systems, Inc.OAR2026-07-30
D125705550R4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
D125705550W4Premium PlusPremium Plus (Dongguan) LimitedJDZ2026-05-20
08058964729163KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16 GG21 SRLOAR2026-05-05
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
15060238201923Vacuum Cement Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-11-18
15060238201725Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201732Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201749HiVac BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201756Rally™ Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201787 MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201794MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10
15060238201886Mixing bowl, SpatulaSUMMIT MEDICAL LIMITEDJDZ2025-01-10
00884450837542StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.OAR2024-12-20