FDA.reportPublic FDA data

Bone-resection orthopaedic reamer, reusable

Definition
An orthopaedic surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). It is commonly called a mill or a reamer and is typically designed as either a preshaped or a solid cylindrical body with an end or circumferential cutting edge. It is attached to a shaft for manual or powered rotation and may be steered over a guide or spigot that has been inserted into the site to control the cutting action. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.
GUDID devices
1,972
Last updated
2020-07-21 18:27:21

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07613327346343NAStryker GmbH2358-20652020-07-13
07613327346428NAStryker GmbH2358-21052020-07-13
07613327346442NAStryker GmbH2358-20852020-07-13
07613327346480NAStryker GmbH2358-20752020-07-13
07613327346497NAStryker GmbH2358-20952020-07-13
07613327409628NAStryker GmbH7058032020-07-13
00885556789650TRIGENSmith & Nephew, Inc.E0017052-12020-07-10
00885556789667TrigenSmith & Nephew, Inc.E0017046-12020-07-09
00885556789568PolarSmith & Nephew, Inc.E0017048-12020-07-07
00885556789575PolarSmith & Nephew, Inc.E0017048-22020-07-07
00888867310124Arthrex®ARTHREX, INC.AR-4158PR-06V2020-07-06
00888867310148Arthrex®ARTHREX, INC.AR-4158PR-08V2020-07-06
00888867310162Arthrex®ARTHREX, INC.AR-4158PR-10V2020-07-06
00888867310179Arthrex®ARTHREX, INC.AR-4158PR-12C2020-07-06
00888867310186Arthrex®ARTHREX, INC.AR-4158PR-12V2020-07-06
00888867331228Arthrex®ARTHREX, INC.AR-4158PR-06C-RU2020-07-06
00888867331235Arthrex®ARTHREX, INC.AR-4158PR-06V-RU2020-07-06
00888867331242Arthrex®ARTHREX, INC.AR-4158PR-08C-RU2020-07-06
00888867331259Arthrex®ARTHREX, INC.AR-4158PR-08V-RU2020-07-06
00888867331266Arthrex®ARTHREX, INC.AR-4158PR-10C-RU2020-07-06
00888867331273Arthrex®ARTHREX, INC.AR-4158PR-10V-RU2020-07-06
00888867331280Arthrex®ARTHREX, INC.AR-4158PR-12C-RU2020-07-06
00888867331297Arthrex®ARTHREX, INC.AR-4158PR-12V-RU2020-07-06
M269RMR09200570001Titan™Ascension Orthopedics, Inc.RR09200570002017-08-30
M269RMR09200570011Titan™Ascension Orthopedics, Inc.RR09200570012017-08-30
M269RMR09200570021Titan™Ascension Orthopedics, Inc.RR09200570022017-08-30
M269RMR09200570031Titan™Ascension Orthopedics, Inc.RR09200570032017-08-30
M268102040571Cadence™Ascension Orthopedics, Inc.102040572016-08-24
00885556788455TrigenSmith & Nephew, Inc.E0017043-12020-06-30
00885556789261TrigenSmith & Nephew, Inc.E0017037-22020-06-26
00885556789278TrigenSmith & Nephew, Inc.E0017037-32020-06-26
00885556789285TrigenSmith & Nephew, Inc.E0017037-42020-06-26
00885556789292TrigenSmith & Nephew, Inc.E0017037-52020-06-26
00885556789308TrigenSmith & Nephew, Inc.E0017037-62020-06-26
00885556789315TrigenSmith & Nephew, Inc.E0017037-72020-06-26
00885556789322TrigenSmith & Nephew, Inc.E0017037-82020-06-26
00885556789339TrigenSmith & Nephew, Inc.E0017037-92020-06-26
00885556789346TrigenSmith & Nephew, Inc.E0017037-102020-06-26
00885556789353TrigenSmith & Nephew, Inc.E0017037-112020-06-26
00885556789360TrigenSmith & Nephew, Inc.E0017037-122020-06-26
00885556789377TrigenSmith & Nephew, Inc.E0017037-132020-06-26
00885556789384TrigenSmith & Nephew, Inc.E0017037-142020-06-26
00885556789391TrigenSmith & Nephew, Inc.E0017037-152020-06-26
00888867324725Arthrex®ARTHREX, INC.AR-9675-S2020-06-27
00888867324732Arthrex®ARTHREX, INC.AR-9675-M2020-06-27
00888867324749Arthrex®ARTHREX, INC.AR-9675-XL2020-06-27
00888867324756Arthrex®ARTHREX, INC.AR-9675-L2020-06-27
00885556789216TrigenSmith & Nephew, Inc.E0017035-12020-06-25
00885556789223TrigenSmith & Nephew, Inc.E0017035-22020-06-25
00885556789230TrigenSmith & Nephew, Inc.E0017035-32020-06-25
00885556789254TrigenSmith & Nephew, Inc.E0017037-12020-06-25
00885556789421TrigenSmith & Nephew, Inc.E0017035-42020-06-25
00885556788462Journey IISmith & Nephew, Inc.E0017010-12020-06-23
07611819310094NASYNTHES (U.S.A.) LP03.025.0292016-12-31
07611819865976NASYNTHES (U.S.A.) LP03.025.1362016-12-31
00885556784280TrigenSmith & Nephew, Inc.E0016992-12020-05-14
00880304313194ALLIANCE TAPERED REAMERBiomet Orthopedics, LLC31-4732012020-05-15
00880304324411BIOMET OFFSETBiomet Orthopedics, LLC32-3415182020-05-15
00880304324497BIOMET OFFSETBiomet Orthopedics, LLC32-3415332020-05-15
00880304327603MAXIM IM ROD / REAMERBiomet Orthopedics, LLC32-3471102020-05-15
00880304328242MODULAR PATELLA MILLBiomet Orthopedics, LLC32-3473602020-05-15
00880304328587BIOMET PATELLA MILLBiomet Orthopedics, LLC32-3478002020-05-15
00880304329478BIOMET REVISIONBiomet Orthopedics, LLC32-3480612020-05-15
00880304329492BIOMET REVISIONBiomet Orthopedics, LLC32-3480632020-05-15
00880304329515BIOMET REVISIONBiomet Orthopedics, LLC32-3480652020-05-15
00880304329522BIOMET REVISIONBiomet Orthopedics, LLC32-3480662020-05-15
00880304329539BIOMET REVISIONBiomet Orthopedics, LLC32-3480672020-05-15
00880304329553BIOMET REVISIONBiomet Orthopedics, LLC32-3480692020-05-15
00880304329577BIOMET REVISIONBiomet Orthopedics, LLC32-3480712020-05-15
00880304329843SERIES 1 INSTRUMENTATIONBiomet Orthopedics, LLC32-3481412020-05-15
00880304329850SERIES 1 INSTRUMENTATIONBiomet Orthopedics, LLC32-3481422020-05-15
00880304329867SERIES 1 INSTRUMENTATIONBiomet Orthopedics, LLC32-3481432020-05-15
00880304329874SERIES 1 INSTRUMENTATIONBiomet Orthopedics, LLC32-3481442020-05-15
00880304329966SINGLE PEG REAMER BASKETBiomet Orthopedics, LLC32-3481642020-05-15
00880304608207EXACT HIP INSTRUMENTATIONBiomet Orthopedics, LLC31-4737932020-05-15
00880304188754MALLORY/HEAD(R) PF FEMORAL REAMERBiomet Orthopedics, LLC1044022020-05-08
00880304188761MALLORY/HEAD(R) REAMERBiomet Orthopedics, LLC1044062020-05-08
00880304188785MALLORY/HEAD(R) REAMERBiomet Orthopedics, LLC1044082020-05-08
00880304188792MALLORY/HEAD(R) REAMERBiomet Orthopedics, LLC1044092020-05-08
00880304188815MALLORY/HEAD(R) REAMERBiomet Orthopedics, LLC1044112020-05-08