FDA.reportPublic FDA data

StabiliT ER2 Bone Cement

Primary DI
00850696006417
Brand
StabiliT ER2 Bone Cement
Company
Dfine, Inc.
Model
1135
Catalog number
1135
Published
2015-12-17
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
NDNCement, Bone, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850696006417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850696006417008506960064178506960064170850696006417

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-medicatedA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
169957607
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850696006004SpineSTAR Ablation Instrument (10 15, Long) STR-1015LSTR-1015L2016-08-23
00850696006011SpineSTAR Ablation Instrument (5 10, Long)STR-0510LSTR-0510L2016-08-23
00850696006240STAR Tumor Ablation Kit (10 15, Short) with PowerCURVERF-1015S-01RF-1015S-012016-08-23
00850696006257STAR Tumor Ablation Kit (5 10, Long) with PowerCURVERF-0510L-01RF-0510L-012016-08-23
00850696006264STAR Tumor Ablation Kit (5 10, Short) with PowerCURVERF-0510S-01RF-0510S-012016-08-23
00850696006271STAR Tumor Ablation Kit (10 15, Long) with PowerCURVERF-1015L-01RF-1015L-012016-08-23
00850696006646STAR Tumor Ablation Kit (5 10, Short) with PowerCURVERF-0510S-01RF-0510S-012016-08-23
00850696006653STAR Tumor Ablation Kit (5 10, Long) with PowerCURVERF-0510L-01RF-0510L-012016-08-23
00850696006660STAR Tumor Ablation Kit (10 15, Short) with PowerCURVERF-1015S-01RF-1015S-012016-08-23
00850696006677STAR Tumor Ablation Kit (10 15, Long) with PowerCURVERF-1015L-01RF-1015L-012016-08-23
00850696006684SpineSTAR Ablation Instrument (5 10, Short)354435442016-08-23
00850696006691SpineSTAR Ablation Instrument (10 15, Short)319231922016-08-23
00850696006028StabiliT Bone Cement and Saturate Mixing System445744572015-12-17
00850696006073StabiliT VP Fracture KitVP-0010AVP-0010A2015-12-11
00850696006226StabiliT First Fracture Kit 2003-12003-12015-11-02
00850696006233StabiliT First Fracture Kit 3353-013353-012016-01-27
00850696006288StabiliT MX Fracture Kit MX-2100L-01MX-1100S2015-11-30
00850696006295StabiliT MX Fracture Kit MX-2100S-01MX-1100S2015-11-30
00850696006301StabiliT MX Fracture Kit MX-1100L-01MX-1100S2015-11-30
00850696006318StabiliT MX Fracture Kit MX-1100S-01MX-1100S2015-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800038029323SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039421SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039438SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039445SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039452SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039469SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08800038039476SteriSpine VA IMEDICOM CO., LTD.NDN2025-09-24
08058964726452Winch Kyphoplasty Kit 15 mmG21 SRLNDN2025-02-26
08058964726469Winch Kyphoplasty Kit 20 mmG21 SRLNDN2025-02-26
08058964726735Winch Kyphoplasty Bilateral Kit 15 mmG21 SRLNDN2025-02-26
08058964727589EasyWinch 15 mmG21 SRLNDN2025-02-26
08058964727596EasyWinch 20 mmG21 SRLNDN2025-02-26
08058964727763Winch Kyphoplasty Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727770Winch Kyphoplasty Bilateral Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727787Winch Kyphoplasty Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727794Winch Kyphoplasty Bilateral Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727817Winch Kyphoplasty Bilateral Kit 20 mmG21 SRLNDN2025-02-26
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
07613327638226OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONNDN2024-09-03