FDA.reportPublic FDA data

Orthopaedic implantation sleeve, single-use

Definition
A sterile, hand-held surgical tubular device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw) and/or facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, to stabilize an instrument/implant coupling, and/or to protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a single-use device.
GUDID devices
99
Last updated
2026-08-03 17:33:54

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00889024709195DRILL MEASURING SLEEVEBiomet Orthopedics, LLC2112-01-4102026-07-24
00810012484183MEASURING SLEEVEBIOPRO, INC.186582019-06-06
07613154570386GAMMAStryker GmbH1320-0125S2020-04-07
008401944960013P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3120-30042026-06-10
008401944962543P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3124-30042026-06-10
008401944971763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3127-30042026-06-10
008401944971833P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3135-30042026-06-10
008100743076114.5mm DRILL SLEEVE, 100mm Osteocentric Technologies, Inc.2004-01212025-10-21
008100743076284.5mm DRILL SLEEVE, 160mm Osteocentric Technologies, Inc.2004-01222025-10-21
10886982068781NASynthes GmbH03.010.437S2015-09-14
10886982068798NASynthes GmbH03.010.438S2015-09-14
10886982194725NASynthes GmbH355.0062016-12-31
10705034534275NADEPUY SPINE, LLC6983435272019-02-27
00850069061616Metalogix RevolutionFUSION ORTHOPEDICS, LLC1006062025-12-09
00850069061647Metalogix RevolutionFUSION ORTHOPEDICS, LLC1006092025-12-09
00850069061661Metalogix RevolutionFUSION ORTHOPEDICS, LLC1006122025-12-09
00840124514133TopLockFUSION ORTHOPEDICS, LLCCD-TL-70352025-09-25
00840124514140TopLockFUSION ORTHOPEDICS, LLCCD-TL-70472025-09-25
00840124521551FuzeFix Max FTFUSION ORTHOPEDICS, LLCTN-CS-79352025-09-17
00840124521568FuzeFix Max FTFUSION ORTHOPEDICS, LLCTN-CS-79402025-09-17
00840124521575FuzeFix Max FTFUSION ORTHOPEDICS, LLCTN-CS-79142025-09-17
00840124521582FuzeFix Max FTFUSION ORTHOPEDICS, LLCTN-CS-79162025-09-17
00840124521636FuzeFix Max FTFUSION ORTHOPEDICS, LLCTN-CS-75402025-09-17
00840124521643FuzeFix Max FTFUSION ORTHOPEDICS, LLCTN-CS-75352025-09-17
00840124518919FuzeFix LargeFUSION ORTHOPEDICS, LLCTN-FX-70902025-05-14
00840124518926FuzeFix LargeFUSION ORTHOPEDICS, LLCTN-FX-70702025-05-14
00840124518933FuzeFix LargeFUSION ORTHOPEDICS, LLCTN-FX-70282025-05-14
00840124519152IntraLockFUSION ORTHOPEDICS, LLCTN-IL-50342025-05-14
00840124519176IntraLockFUSION ORTHOPEDICS, LLCTN-IL-50272025-05-14
00840124518896FuzeFix LargeFUSION ORTHOPEDICS, LLCTN-FX-70202025-05-13
00840124518902FuzeFix LargeFUSION ORTHOPEDICS, LLCTN-FX-70552025-05-13
00888867430129Arthrex®ARTHREX, INC.AR-9099-12S2024-10-18
00888867430136Arthrex®ARTHREX, INC.AR-9099-29S2024-10-18
00887868582097Affixus®Zimmer, Inc.2113000072024-10-17
00887868582127Affixus®Zimmer, Inc.2113000102024-10-17
10886982344427NASynthes GmbH03.043.037S2024-03-13
10886982344434NASynthes GmbH03.043.038S2024-03-13
10886982345745NASynthes GmbH03.043.035S2024-03-13
10886982345752NASynthes GmbH03.043.036S2024-03-13
03596010510952NASmith & Nephew, Inc.72100382015-08-30
00889797104517N/AWRIGHT MEDICAL TECHNOLOGY, INC.58PM2SLV2023-08-08
B058SLNT441Exchange TubeOrthopedic Designs North America, Inc.SLNT442023-07-06
00885556813669TRIGENSmith & Nephew, Inc.719358762023-03-06
00885556813676TRIGENSmith & Nephew, Inc.719358772023-03-06
10886982298829NASynthes GmbH03.043.007S2023-02-06
00889797071390SALVATIONWRIGHT MEDICAL TECHNOLOGY, INC.SMN100122022-11-16
00889797076760ORTHOLOCWRIGHT MEDICAL TECHNOLOGY, INC.381400112022-09-24
00842048151708F1 MPSDEGEN MEDICAL, INC.01-30R2022-08-22
00842048154365DeGen Standard InstrumentationDEGEN MEDICAL, INC.97-15R2022-08-22
00842048154372DeGen Standard InstrumentationDEGEN MEDICAL, INC.97-16R2022-08-22
00842048154556DeGen Standard InstrumentationDEGEN MEDICAL, INC.97-34R2022-08-22
10886982298843NASynthes GmbH03.043.011S2022-05-24
008169500297214.0 X 30MM DRILL SLEEVEOsteocentric Technologies, Inc.303-40022022-02-16
008169500297525.0 X 60MM DRILL SLEEVEOsteocentric Technologies, Inc.303-50022022-02-16
008169500297835.0 X 120MM DRILL SLEEVEOsteocentric Technologies, Inc.303-50052022-02-16
008169500298136.0 X 90MM DRILL SLEEVEOsteocentric Technologies, Inc.303-60022022-02-16
008169500298446.0 X 120MM DRILL SLEEVEOsteocentric Technologies, Inc.303-60052022-02-16
10886982298867NASynthes GmbH03.043.034S2021-10-29
00887868453656A.L.P.S.® Proximal Humerus Plating SystemBiomet Orthopedics, LLC1100175712021-08-23
00887868453922A.L.P.S.® Proximal Humerus Plating SystemBiomet Orthopedics, LLC1100176622021-08-23
10886982298850NASynthes GmbH03.043.033S2021-05-25
00880304835269A.L.P.S.®Biomet Orthopedics, LLC2142353002021-04-27
00887868445729A.L.P.S.®Biomet Orthopedics, LLC8563-01-0052020-09-04
00889797076708ORTHOLOC™ 2 LapiFuse™WRIGHT MEDICAL TECHNOLOGY, INC.381400032020-07-17
07640156475371Guiding sleeveThommen Medical AG3.03.141Q42020-07-13
07640182640620Guide sleeveThommen Medical AG3.04.080Q42020-07-13
00887868062360A.L.P.S.MEASURING DRILL SLEEVEBiomet Orthopedics, LLC8563-01-0052017-07-28
00887868023415DRILL MEASURING SLEEVEBiomet Orthopedics, LLC2112-01-4102017-04-18
00840420195098MICAWRIGHT MEDICAL TECHNOLOGY, INC.577002092018-01-29
00840420195104MICAWRIGHT MEDICAL TECHNOLOGY, INC.577002142018-01-29
04546540195876NAStryker GmbH1806-0073S2020-04-07
00819917027020Cannulated Compression Headless ScrewTyber Medical, LLC03.333.7002019-06-13
00819917027044Cannulated Compression Headless ScrewTyber Medical, LLC03.333.7012019-06-13
00819917027051Cannulated Compression Headless ScrewTyber Medical, LLC03.333.7022019-06-13
00819917027075Cannulated Compression Headless ScrewTyber Medical, LLC03.333.7032019-06-13
00810012484176REDUCTION SLEEVEBIOPRO, INC.186572019-06-06
00819034027293FuzeFix LargeFUSION ORTHOPEDICS, LLCTN-FX-70202019-04-22
00819034027309FuzeFix LargeFUSION ORTHOPEDICS, LLCTN-FX-70552019-04-22
00819034027316FuzeFix LargeFUSION ORTHOPEDICS, LLCTN-FX-70902019-04-22
00819034027323FuzeFix LargeFUSION ORTHOPEDICS, LLCTN-FX-70702019-04-22