FDA.reportPublic FDA data

Speed

Primary DI
00810633020197
Brand
Speed
Company
Biomedical Enterprises, Inc.
Model
SE-1818
Device description
SPEED 18X18X18mm implant
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRStaple, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810633020197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810633020197008106330201978106330201970810633020197

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustable, sterileA sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Millimeter
Width18Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00May be stored at room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
210-881-0043gupton@bme-tx.com
210-881-0064aknight@bme-tx.com

Regulatory Flags#

DUNS number
792619009
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810633020005HammerLockHLXM2015-10-24
00810633020012HammerLockHLDIP2015-10-24
00810633020029HammerLockHLXL2015-10-24
00810633020036HammerLockHLXLA2015-10-24
00810633020043HammerLockHLXMA2015-10-24
00810633020050HammerLockHLXP2015-10-24
00810633020067HammerLockHLXS2015-10-24
00810633020074HammerLockHLXSA2015-10-24
00810633021361HammerLockHLXM2015-10-24
00810633021378HammerLockHLDIP2015-10-24
00810633021385HammerLockHLXL2015-10-24
00810633021392HammerLockHLXLA2015-10-24
00810633020173SpeedSE-15152015-10-24
00810633020180SpeedSE-18152015-10-24
00810633020203SpeedSE-1818152015-10-24
00810633020210SpeedSE-20152015-10-24
00810633020227SpeedSE-20202015-10-24
00810633020234SpeedSE-25202015-10-24
00810633020258SpeedLS-09072015-10-24
00810633020265SpeedLS-09102015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227223SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111227247SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111227254SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111224062TMC SpeedMTPTreace Medical Concepts, Inc.JDR2026-03-30
00810135964180VertexNVision Biomedical Technologies, Inc.JDR2025-12-17
00810111224833TMC Nanoplasty SystemTreace Medical Concepts, Inc.JDR2025-10-10
00860005968824RELJA Innovations Nitinol Staple Kit 15mmx12mmRelja Innovations LLCJDR2025-09-19
00860005968831RELJA Innovations Nitinol Staple Kit 18x18Relja Innovations LLCJDR2025-09-19
00811714036458Thunderbolt RESPONSIVE ORTHOPEDICS LLCJDR2025-05-14
00811714036465Thunderbolt RESPONSIVE ORTHOPEDICS LLCJDR2025-05-14
10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
00810111223683SpeedPlate - SpeedAkinTreace Medical Concepts, Inc.JDR2025-01-27
00810111223485TMC SpeedMTPTreace Medical Concepts, Inc.JDR2024-11-18
07630037889397APTUSMedartis AGJDR2023-03-03
10888867042633Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042640Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042671Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042688Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042695Arthrex®ARTHREX, INC.JDR2021-12-03
00811714035345Thunderbolt Suture AssemblyRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
00811714035352Thunderbolt PlateRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
00810005661010VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661027VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661034VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661041VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661058VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661065VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661072VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661089VertexNVision Biomedical Technologies, Inc.JDR2020-12-28