FDA.reportPublic FDA data

Orthopaedic cement preparation/delivery kit

Definition
A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.
GUDID devices
538
Last updated
2026-10-04 01:44:39

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00808232001020AliquotStryker Corporation2090-05012017-12-20
00808232001037AliquotStryker Corporation2090-05022017-12-20
00808232001051AliquotStryker Corporation2090-05042017-12-20
00808232001068AliquotStryker Corporation2090-05052017-12-20
00808232001150AliquotStryker Corporation2110-05132017-12-20
00808232001372CortossStryker Corporation2110-00392015-09-24
07613327175738LITe BIO Delivery SystemStryker Corporation482882142016-08-15
07613327175752LITe BIO Delivery SystemStryker Corporation482882122016-08-15
07613327175769LITe BIO Delivery SystemStryker Corporation482882152016-08-15
07613327175776LITe BIO Delivery SystemStryker Corporation482882112016-08-15
07613327175783LITe BIO Delivery SystemStryker Corporation482882132016-08-15
07613327263756RELIANCE LITeStryker Corporation480655002019-10-14
07613327263848RELIANCE LITeStryker Corporation480650002019-10-14
07613327524000LITe BioStryker CorporationIS4474REL2021-03-03
30808232000949CortossStryker Corporation2110-00312015-09-24
30808232001137AliquotStryker Corporation2110-05072017-12-20
00884450587713StabiliT®Merit Medical Systems, Inc.D2026-07-30
07613327141818VertaPlexSTRYKER CORPORATION04064220002016-09-23
00884450296158DFINE®Merit Medical Systems, Inc.008844502961582018-06-11
00884450296172DFINE®Merit Medical Systems, Inc.008844502961722018-05-03
00884450296271StabiliT®Merit Medical Systems, Inc.008844502962712017-01-23
00884450296301StabiliT®Merit Medical Systems, Inc.008844502963012017-01-27
00884450296318DFINE®Merit Medical Systems, Inc.008844502963182017-06-02
00884450296356DFINE®Merit Medical Systems, Inc.008844502963562018-09-28
00884450296431DFINE®Merit Medical Systems, Inc.008844502964312020-01-02
00884450296462StabiliT®Merit Medical Systems, Inc.008844502964622018-09-13
00884450296509StabiliT®Merit Medical Systems, Inc.008844502965092018-09-13
00884450314319StabiliT®Merit Medical Systems, Inc.008844503143192018-09-13
00884450314487StabiliT®Merit Medical Systems, Inc.008844503144872018-01-03
00884450315897StabiliT®Merit Medical Systems, Inc.008844503158972018-01-03
00884450315903StabiliT®Merit Medical Systems, Inc.008844503159032017-06-02
00884450315910StabiliT®Merit Medical Systems, Inc.008844503159102018-04-03
00884450315927StabiliT®Merit Medical Systems, Inc.008844503159272018-04-10
00884450317631StabiliT®Merit Medical Systems, Inc.008844503176312018-01-15
00884450317648StabiliT®Merit Medical Systems, Inc.008844503176482018-01-15
00884450317655StabiliT®Merit Medical Systems, Inc.008844503176552018-09-13
00884450317662StabiliT®Merit Medical Systems, Inc.008844503176622019-02-08
00884450325605StabiliT®Merit Medical Systems, Inc.008844503256052018-04-17
00884450325612StabiliT®Merit Medical Systems, Inc.008844503256122018-09-13
00884450325643StabiliT®Merit Medical Systems, Inc.008844503256432018-09-13
00884450325667StabiliT®Merit Medical Systems, Inc.008844503256672018-11-15
00884450325704StabiliT®Merit Medical Systems, Inc.008844503257042018-09-13
00884450325766StabiliT®Merit Medical Systems, Inc.008844503257662018-09-13
00884450379820StabiliT®Merit Medical Systems, Inc.008844503798202018-08-20
00884450379837StabiliT®Merit Medical Systems, Inc.008844503798372019-01-18
00884450379844StabiliT®Merit Medical Systems, Inc.008844503798442018-09-17
00884450379851StabiliT®Merit Medical Systems, Inc.008844503798512018-04-11
00884450379905StabiliT®Merit Medical Systems, Inc.008844503799052019-09-13
00884450413999StabiliT®Merit Medical Systems, Inc.008844504139992019-10-31
00884450441459StabiliT®Merit Medical Systems, Inc.008844504414592019-10-04
00884450492468StabiliT®Merit Medical Systems, Inc.B2022-12-17
00884450503331StabiliT®Merit Medical Systems, Inc.008844505033312021-01-12
00884450662144StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.008844506621442022-10-04
00884450837542StabiliT TOUCH™ SyringeMerit Medical Systems, Inc.C2024-12-20
03596010033284NASmith & Nephew, Inc.1100322015-08-29
03596010033291NASmith & Nephew, Inc.1100332015-08-29
03596010036971CONCISESmith & Nephew, Inc.1110002015-08-29
03596010038869NASmith & Nephew, Inc.1114312015-08-29
03596010038876NASmith & Nephew, Inc.1114322015-08-29
03596010038883NASmith & Nephew, Inc.1114332015-08-29
03596010038906NASmith & Nephew, Inc.1114352015-08-29
03596010269676NASmith & Nephew, Inc.8900952015-08-30
03596010453211VORTEXSmith & Nephew, Inc.712700702015-08-29
03596010456434VORTEXSmith & Nephew, Inc.712700852015-08-29
03596010457080VORTEXSmith & Nephew, Inc.712700812015-08-29
03596010457097VORTEXSmith & Nephew, Inc.712700842015-08-29
03596010457127PREP-IMSmith & Nephew, Inc.1210102015-08-29
03596010464873VORTEXSmith & Nephew, Inc.712700822015-08-29
03760177043084HIGH V+ SPINAL CEMENT SYSTEMTEKNIMEDT040321K2017-08-22
04260056880612EASYMIX® Nozzle slimOSARTIS GmbH02-01042022-12-01
04260056880919EASYMIX® Nozzle revisionOSARTIS GmbH02-01052022-12-01
04260056884412EASYMIX proOSARTIS GmbH02-03052021-11-11
04260277177768icotec Instrument Cement CannulaMöller Medical GmbH100021192020-10-23
04546540039644NASTRYKER CORPORATION02067110002018-09-24
04546540039651NASTRYKER CORPORATION02067140002018-09-24
04546540039668NASTRYKER CORPORATION02067160002018-09-24
04546540055392ACMSTRYKER CORPORATION03065530002018-09-24
04546540055422ACM BioPrepSTRYKER CORPORATION03067050002015-09-24
04546540255853HowmedicaSTRYKER CORPORATION61980015142018-09-24
04546540447913RevolutionSTRYKER CORPORATION06065930002018-01-16