FDA.reportPublic FDA data

Orthopaedic bone-fragment manipulator, single-use

Definition
A hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. This is a single-use device.
GUDID devices
42
Last updated
2026-07-17 22:01:56

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00190446924838Arsenal FootTrilliant Surgical, LLC330-22-0022026-06-24
00190446948469Arsenal FootTrilliant Surgical, LLC330-84-0052026-06-24
00190446948476Arsenal FootTrilliant Surgical, LLC330-84-0062026-06-24
00190446900498Arsenal FootTrilliant Surgical, LLC330-60-0072026-06-25
00190446900504Arsenal FootTrilliant Surgical, LLC330-60-0082026-06-25
00190446934196Arsenal FootTrilliant Surgical, LLC330-00-0242026-06-25
00190446934202Arsenal FootTrilliant Surgical, LLC330-00-0232026-06-25
00190446948377Arsenal FootTrilliant Surgical, LLC330-84-0012026-06-25
00190446948438Arsenal FootTrilliant Surgical, LLC330-84-0022026-06-25
00190446948582Arsenal FootTrilliant Surgical, LLC330-60-0102026-06-25
10887587011370MatrixRIBSynthes GmbH03.501.7042016-12-31
10887587014166NASynthes GmbH03.507.002S2016-12-31
10887587040417NASynthes GmbH386.9022016-12-31
M9701300050240Item Master, Guide Pin, 2.4mm, Trocar Tip, 9inMedshape, Inc.1300-05-0242023-08-21
M97022002400040DynaNailMedshape, Inc.2200-24-00042025-10-16
M97022003100000DynaNailMedshape, Inc.2200-31-00002025-10-16
M97022003200000DynaNailMedshape, Inc.2200-32-00002025-10-16
M97022003300000DynaNailMedshape, Inc.2200-33-00002025-10-16
M97022003500000DynaNailMedshape, Inc.2200-35-00002025-10-16
M9702900160700DynaNail Mini Medshape, Inc.2900-16-0702025-01-03
00190446898801Arsenal FootTrilliant Surgical, LLC330-60-0062026-03-19
10887587078571NASynthes GmbHSD386.9022026-02-11
04046826543310MediconMedicon eG. Chirurgiemechaniker-Genossenschaft68.50.132025-08-11
M97029002402500DynaNail MiniMedshape, Inc.2900-24-02502023-06-21
M97015000400000EclipseMedshape, Inc.1500-04-00002023-01-10
M97022001100010DynaNailMedshape, Inc.2200-11-00012023-05-05
M97022002900000DynaNailMedshape, Inc.2200-29-00002016-06-17
M9702300010500EclipseMedshape, Inc.2300-01-0502023-01-10
M9702300010550EclipseMedshape, Inc.2300-01-0552023-01-10
M9702300010600EclipseMedshape, Inc.2300-01-0602023-01-10
M9702300010700EclipseMedshape, Inc.2300-01-0702023-01-10
M9702300010800EclipseMedshape, Inc.2300-01-0802023-01-10
M9702300010900EclipseMedshape, Inc.2300-01-0902023-01-10
M97029000103000DynaNail Mini Medshape, Inc.2900-01-03002023-06-12
M97029000700000DynaNail MiniMedshape, Inc.2900-07-00002019-04-09
00842188127984Tools - WS3Trimed, INC.SBOLT2.4-222024-03-11
00842188128042Tools - WS3Trimed, INC.SBOLT2.4-262024-03-11
M9701300030240Guide Pin, Surgibit Tip 2.4mm DiameterMedshape, Inc.1300-03-0242023-08-21
M970ED108010200Pin, 3.0mm, DynaClip Staple, 2.0mmMedshape, Inc.ED-10801-0202023-08-15
M970ED108010300Pin, 3.0mm, DynaClip Staple, 3.0mmMedshape, Inc.ED-10801-0302023-08-15
M97022001900200DynaNailMedshape, Inc.2200-19-00202023-06-22
M97029002100010DynaNail MiniMedshape, Inc.2900-21-00012023-06-14