FDA.reportPublic FDA data

Speed Titan

Primary DI
00810633021569
Brand
Speed Titan
Company
Biomedical Enterprises, Inc.
Model
SE-2020TI
Device description
Speed TITAN 20x20x20mm Implant Kit
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
00810633021569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810633021569008106330215698106330215690810633021569

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
Width20Millimeter

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
210-881-0064aknight@bme-tx.com
1-800-255-2500xx@xx.xx
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
792619009
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810633022047N/AStandard46.239.0012020-03-24
00810633022054N/ALarge46.239.0022020-03-24
00810633022085N/ADK-200C2020-03-24
00810633022092N/ADK-265C2020-03-24
00810633020005HammerLockHLXM2015-10-24
00810633020012HammerLockHLDIP2015-10-24
00810633020029HammerLockHLXL2015-10-24
00810633020036HammerLockHLXLA2015-10-24
00810633020043HammerLockHLXMA2015-10-24
00810633020050HammerLockHLXP2015-10-24
00810633020067HammerLockHLXS2015-10-24
00810633020074HammerLockHLXSA2015-10-24
00810633020104SpeedSE-09072015-10-24
00810633020111SpeedSE-09102015-10-24
00810633020128SpeedSE-11102015-10-24
00810633020135SpeedSE-1115132015-10-24
00810633020142SpeedSE-13102015-10-24
00810633020159SpeedSE-1315132015-10-24
00810633020166SpeedSE-15122015-10-24
00810633020173SpeedSE-15152015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060267134523Fastlok 8mm x 23mmXIROS LTDJDR2026-02-16
05060267134530Fastlok 6mm x 23mmXIROS LTDJDR2026-02-16
10193489020892MEDLINEMEDLINE INDUSTRIES, INC.JDR2026-02-10
10193489020915MEDLINEMEDLINE INDUSTRIES, INC.JDR2026-02-10
10193489020946MEDLINEMEDLINE INDUSTRIES, INC.JDR2026-02-10
00810111225236Lapiplasty SpeedPlate - TMTTreace Medical Concepts, Inc.JDR2026-01-23
00810135964180VertexNVISION BIOMEDICAL TECHNOLOGIES, INC.JDR2025-12-17
00810111224918TMC FastPitch ScrewsTreace Medical Concepts, Inc.JDR2025-12-12
00810111225175TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111225199TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111225373TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111224857TMC SpeedMTPTreace Medical Concepts, Inc.JDR2025-11-14
00860005968824RELJA Innovations Nitinol Staple Kit 15mmx12mmRelja Innovations LLCJDR2025-09-19
00860005968831RELJA Innovations Nitinol Staple Kit 18x18Relja Innovations LLCJDR2025-09-19
00854325007004Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007011Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007028Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007035Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007042Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007059Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007066Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007073Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007080Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007097Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007103Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007110Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007127Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007134Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007141Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007158Reign MedicalF & A Foundation LLCJDR2025-09-05