FDA.reportPublic FDA data

N/A

Primary DI
00885556697986
Brand
N/A
Company
Smith & Nephew, Inc.
Model
74018904
Catalog number
74018904
Device description
LEGION GII CR LOCKING FEMORAL IMPACTOR BUMPER
Published
2018-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXBPROBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556697986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556697986008855566979868855566979860885556697986

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150069675Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-03-20
10705034577449N/AMedos International SàrlHXB2026-03-05
10889981443436SpecialsSeaspine Orthopedics CorporationHXB2026-03-03
10888857578197Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578203Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578630Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578647Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578654Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578661Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578678Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578685Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578692Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578708Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
03662663131551Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131568Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131575Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131582Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131599Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131605Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131612Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
00860014213458Introducer ProbeTETROUS, INC.HXB2026-02-10
00860014213472Pusher ProbeTETROUS, INC.HXB2026-02-10
00860014213496Introducer Probe - SJTETROUS, INC.HXB2026-02-10
00810158218833PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218840PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218857PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218864PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
10889981441531SpecialsSeaspine Orthopedics CorporationHXB2026-01-30
00840180544013General InstrumentsALPHATEC SPINE, INC.HXB2026-01-29
00840180545188General InstrumentsALPHATEC SPINE, INC.HXB2026-01-29