FDA.reportPublic FDA data

Orthopaedic bone staple, non-adjustable

Definition
A 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. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.
GUDID devices
514
Last updated
2026-07-17 21:59:27

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860005968824RELJA Innovations Nitinol Staple Kit 15mmx12mmRelja Innovations LLCRI-NS-152025-09-19
00860005968831RELJA Innovations Nitinol Staple Kit 18x18Relja Innovations LLCRI-NS-182025-09-19
00888867042377Arthrex®ARTHREX, INC.AR-8004-15S2017-02-15
00810111224062TMC SpeedMTPTreace Medical Concepts, Inc.NK292026-03-30
00810111227223SpeedMTP SelectTreace Medical Concepts, Inc.SK692026-05-13
00810111227247SpeedMTP SelectTreace Medical Concepts, Inc.SD342026-05-13
00810111227254SpeedMTP SelectTreace Medical Concepts, Inc.SD332026-05-13
00854325007196RELJA Innovations Nitinol Staple Kit 15mm x 12mmF & A Foundation LLCRI-NS-152026-04-10
00854325007202RELJA Innovations Nitinol Staple Kit 18mm x 18mmF & A Foundation LLCRI-NS-182026-04-10
00860012784707Toetal Implant, Packaged, 3mm, 16mmToetal Solutions IncT-60-0002-012026-04-02
00860012784714Toetal Implant, Packaged, 3mm, 18mmToetal Solutions IncT-60-0002-022026-04-02
00860012784721Toetal Implant, Packaged, 3mm, 20mmToetal Solutions IncT-60-0002-032026-04-02
00860012784738Toetal Implant, Packaged, 3mm, 22mmToetal Solutions IncT-60-0002-042026-04-02
00860012784745Toetal Implant, Packaged, 3mm, 24mmToetal Solutions IncT-60-0002-052026-04-02
07630037889397APTUSMedartis AGA-4090.04S2023-03-03
10381780052364SOLUSTAPLENEWDEAL114002ND2017-10-09
10381780052388SOLUSTAPLENEWDEAL114004ND2017-10-09
10381780052401SOLUSTAPLENEWDEAL114023ND2017-10-09
10381780052425SOLUSTAPLENEWDEAL114025ND2017-10-09
10381780052449UNI-CLIPNEWDEAL213113ND2017-10-09
10381780052463UNI-CLIPNEWDEAL213114ND2017-10-09
10381780052487UNI-CLIPNEWDEAL213115ND2017-10-09
10381780052500UNI-CLIPNEWDEAL213116ND2017-10-09
10381780052548UNI-CLIPNEWDEAL213213ND2017-10-09
10381780052562UNI-CLIPNEWDEAL213214ND2017-10-09
10381780052586UNI-CLIPNEWDEAL213215ND2017-10-09
10381780052647UNI-CLIPNEWDEAL213313ND2017-10-09
10381780052661UNI-CLIPNEWDEAL213314ND2017-10-09
10381780052746UNI-CLIPNEWDEAL213512ND2017-10-09
10381780052814Large UNI-CLIPNEWDEAL314827SND2015-09-24
10381780074298Integra® MemoFix®Ascension Orthopedics, Inc.STAPLEIMP2015-09-26
10381780121343Integra® MemoFix®Ascension Orthopedics, Inc.MS0808082017-10-09
10381780121350Integra® MemoFix®Ascension Orthopedics, Inc.MS1010102017-10-09
10381780121367Integra® MemoFix®Ascension Orthopedics, Inc.MS1015132017-10-09
10381780121374Integra® MemoFix®Ascension Orthopedics, Inc.MS1017152017-10-09
10381780121381Integra® MemoFix®Ascension Orthopedics, Inc.MS1210102017-10-09
10381780121398Integra® MemoFix®Ascension Orthopedics, Inc.MS1215132017-10-09
10381780121404Integra® MemoFix®Ascension Orthopedics, Inc.MS1217152017-10-09
10381780121411Integra® MemoFix®Ascension Orthopedics, Inc.MS1219162017-10-09
10381780121428Integra® MemoFix®Ascension Orthopedics, Inc.MS1512122017-10-09
10381780121435Integra® MemoFix®Ascension Orthopedics, Inc.MS1515152017-10-09
10381780121442Integra® MemoFix®Ascension Orthopedics, Inc.MS1812122017-10-09
10381780121459Integra® MemoFix®Ascension Orthopedics, Inc.MS1814142017-10-09
10381780121466Integra® MemoFix®Ascension Orthopedics, Inc.MS1817152017-10-09
10381780121473Integra® MemoFix®Ascension Orthopedics, Inc.MS1819172017-10-09
10381780121480Integra® MemoFix®Ascension Orthopedics, Inc.MS2015152017-10-09
10381780121497Integra® MemoFix®Ascension Orthopedics, Inc.MS2020202017-10-09
10381780121503Integra® MemoFix®Ascension Orthopedics, Inc.MS2520202017-10-09
10381780121510Integra® MemoFix®Ascension Orthopedics, Inc.MS2522222017-10-09
10845854015575STAPLIZERConmed Corporation7707-032015-10-24
10845854015582STAPLIZERConmed Corporation7625-032015-10-24
10845854015599STAPLIZERConmed Corporation7307-032015-10-24
10845854015674STAPLIZERConmed Corporation7015-032015-10-24
10845854015681STAPLIZERConmed Corporation7320-032015-10-24
10845854015773STAPLIZERConmed Corporation7620-032015-10-24
10845854015780STAPLIZERConmed Corporation7610-032015-10-24
10845854015926STAPLIZERConmed Corporation7007-032015-10-24
10845854016046STAPLIZERConmed Corporation7310-032015-10-24
10845854016060STAPLIZERConmed Corporation7315-032015-10-24
10845854016282STAPLIZERConmed Corporation7010-032015-10-24
10845854016299STAPLIZERConmed Corporation7710-032015-10-24
10845854016428STAPLIZERConmed Corporation7615-032015-10-24
10886982179715NASynthes GmbH282.802015-09-14
10886982179722NASynthes GmbH282.822015-09-14
10193489020892MEDLINEMEDLINE INDUSTRIES, INC.MSK415182026-02-10
10193489020915MEDLINEMEDLINE INDUSTRIES, INC.MSK418202026-02-10
10193489020946MEDLINEMEDLINE INDUSTRIES, INC.MSK525202026-02-10
00810111225236Lapiplasty SpeedPlate - TMTTreace Medical Concepts, Inc.SK682026-01-23
00810135964180VertexNVISION BIOMEDICAL TECHNOLOGIES, INC.STK-20-16-162025-12-17
00810111224918TMC FastPitch ScrewsTreace Medical Concepts, Inc.SD312025-12-12
00810111225175TMC SpeedTMTTreace Medical Concepts, Inc.02-004022025-12-12
00810111225199TMC SpeedTMTTreace Medical Concepts, Inc.SK642025-12-12
00810111224857TMC SpeedMTPTreace Medical Concepts, Inc.SK652025-11-14
00810111224758TMC Nanoplasty SystemTreace Medical Concepts, Inc.02-003962025-10-10
00810111224802TMC Nanoplasty SystemTreace Medical Concepts, Inc.SK672025-10-10
00854325007004Reign MedicalF & A Foundation LLC152-307052025-09-05
00854325007011Reign MedicalF & A Foundation LLC152-309072025-09-05
00854325007028Reign MedicalF & A Foundation LLC152-311102025-09-05
00854325007035Reign MedicalF & A Foundation LLC152-313102025-09-05
00854325007042Reign MedicalF & A Foundation LLC152-315122025-09-05