FDA.reportPublic FDA data

Orthopaedic bone staple, non-adjustable, sterile

Definition
A 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.
GUDID devices
794
Last updated
2021-11-10 08:08:59

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M268MS0808081Integra® MemoFix®Ascension Orthopedics, Inc.MS0808082017-10-09
M268MS1010101Integra® MemoFix®Ascension Orthopedics, Inc.MS1010102017-10-09
M268MS1015131Integra® MemoFix®Ascension Orthopedics, Inc.MS1015132017-10-09
M268MS1017151Integra® MemoFix®Ascension Orthopedics, Inc.MS1017152017-10-09
M268MS1210101Integra® MemoFix®Ascension Orthopedics, Inc.MS1210102017-10-09
M268MS1215131Integra® MemoFix®Ascension Orthopedics, Inc.MS1215132017-10-09
M268MS1217151Integra® MemoFix®Ascension Orthopedics, Inc.MS1217152017-10-09
M268MS1219161Integra® MemoFix®Ascension Orthopedics, Inc.MS1219162017-10-09
M268MS1512121Integra® MemoFix®Ascension Orthopedics, Inc.MS1512122017-10-09
M268MS1515151Integra® MemoFix®Ascension Orthopedics, Inc.MS1515152017-10-09
M268MS1812121Integra® MemoFix®Ascension Orthopedics, Inc.MS1812122017-10-09
M268MS1814141Integra® MemoFix®Ascension Orthopedics, Inc.MS1814142017-10-09
M268MS1817151Integra® MemoFix®Ascension Orthopedics, Inc.MS1817152017-10-09
M268MS1819171Integra® MemoFix®Ascension Orthopedics, Inc.MS1819172017-10-09
M268MS2015151Integra® MemoFix®Ascension Orthopedics, Inc.MS2015152017-10-09
M268MS2020201Integra® MemoFix®Ascension Orthopedics, Inc.MS2020202017-10-09
M268MS2520201Integra® MemoFix®Ascension Orthopedics, Inc.MS2520202017-10-09
M268MS2522221Integra® MemoFix®Ascension Orthopedics, Inc.MS2522222017-10-09
00889797103404EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS215122021-10-14
00889797103411EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS215152021-10-14
00889797103428EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS215202021-10-14
00889797103435EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS218152021-10-14
00889797103442EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS218202021-10-14
00889797103459EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS218252021-10-14
00889797103466EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS220152021-10-14
00889797103473EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS220202021-10-14
00889797103480EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS220252021-10-14
00889797103497EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS225202021-10-14
00889797103503EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS225252021-10-14
00889797103510EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS425202021-10-14
00889797103527EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS430202021-10-14
00889797103534EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS4MTPS2021-10-14
00889797103541EasyFuse™WRIGHT MEDICAL TECHNOLOGY, INC.FFS4MTPL2021-10-14
G0792001176220TruTrack Memory Staple SystemIntelivation, LLC2001.176222021-06-25
G0792001176230TruTrack Memory Staple SystemIntelivation, LLC2001.176232021-06-25
G0792001176240TruTrack Memory Staple SystemIntelivation, LLC2001.176242021-06-25
G0792001176250TruTrack Memory Staple SystemIntelivation, LLC2001.176252021-06-25
G0792001176260TruTrack Memory Staple SystemIntelivation, LLC2001.176262021-06-25
G0792001176270TruTrack Memory Staple SystemIntelivation, LLC2001.176272021-06-25
G0792001176280TruTrack Memory Staple SystemIntelivation, LLC2001.176282021-06-25
G0792001176290TruTrack Memory Staple SystemIntelivation, LLC2001.176292021-06-25
G0792001176300TruTrack Memory Staple SystemIntelivation, LLC2001.176302021-06-25
G0792001176310TruTrack Memory Staple SystemIntelivation, LLC2001.176312021-06-25
G0792001176320TruTrack Memory Staple SystemIntelivation, LLC2001.176322021-06-25
G0792001176330TruTrack Memory Staple SystemIntelivation, LLC2001.176332021-06-25
G0792001176340TruTrack Memory Staple SystemIntelivation, LLC2001.176342021-06-25
G0792001176350TruTrack Memory Staple SystemIntelivation, LLC2001.176352021-06-25
G0792001176360TruTrack Memory Staple SystemIntelivation, LLC2001.176362021-06-25
G0792001176370TruTrack Memory Staple SystemIntelivation, LLC2001.176372021-06-25
G0792001176380TruTrack Memory Staple SystemIntelivation, LLC2001.176382021-06-25
07612334226655EliteSynthes GmbHEL-1815S22021-05-21
07612334226662EliteSynthes GmbHEL-2015S22021-05-21
07612334226679EliteSynthes GmbHEL-2520S22021-05-21
07630345719133Ligament StapleMedacta International SA05.12.10.00062021-04-14
07630971258594Ligament StapleMedacta International SA05.12.0012021-04-14
00815432028894HiMAX CCROSSROADS EXTREMITY SYSTEMS7118-1814-C2020-12-30
03701173703657DynafitSystemNEOSTEOA50808082020-12-15
03701173703664DynafitSystemNEOSTEOA51010102020-12-15
03701173703671DynafitSystemNEOSTEOA51013152020-12-15
03701173703688DynafitSystemNEOSTEOA51015172020-12-15
03701173703695DynafitSystemNEOSTEOA51017192020-12-15
03701173703701DynafitSystemNEOSTEOA51210102020-12-15
03701173703718DynafitSystemNEOSTEOA51213152020-12-15
03701173703725DynafitSystemNEOSTEOA51215172020-12-15
03701173703732DynafitSystemNEOSTEOA51217192020-12-15
03701173703749DynafitSystemNEOSTEOA51512122020-12-15
03701173703756DynafitSystemNEOSTEOA51515152020-12-15
03701173703763DynafitSystemNEOSTEOA51812122020-12-15
03701173703770DynafitSystemNEOSTEOA51815152020-12-15
03701173705460DynafitSystemNEOSTEOA51815172020-12-15
03701173705477DynafitSystemNEOSTEOA51817192020-12-15
03701173705484DynafitSystemNEOSTEOA52016162020-12-15
03701173705491DynafitSystemNEOSTEOA52020202020-12-15
03701173705507DynafitSystemNEOSTEOA52522222020-12-15
10815375021652Stapix Superelastic Nitinol Staple SystemRestore Surgical LLCSK9882015-10-17
10815375021669Stapix Superelastic Nitinol Staple SystemRestore Surgical LLCSK1010102015-10-17
10815375021676Stapix Superelastic Nitinol Staple SystemRestore Surgical LLCSK1210102015-10-17
10815375021683Stapix Superelastic Nitinol Staple SystemRestore Surgical LLCSK1412122015-10-17
10815375021690Stapix Superelastic Nitinol Staple SystemRestore Surgical LLCSK1614142015-10-17
10815375021706Stapix Superelastic Nitinol Staple SystemRestore Surgical LLCSK1816162015-10-17