FDA.report

LARGE CANNULATED SCREWS

Primary DI
03596010064059
Brand
LARGE CANNULATED SCREWS
Company
Smith & Nephew, Inc.
Model
121659
Catalog number
121659
Device description
CANNULATED HIP PIN 55MM
Published
2017-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JDODEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Product Code Classifications

CodeDeviceSpecialtyClass
JDODevice, Fixation, Proximal Femoral, ImplantOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010064059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010064059035960100640593596010064059

GMDN Terms

TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
045483575
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
008100743075366.0 x 55mm Bone Screw Fastener STOsteocentric Technologies, Inc.JDO2025-09-26
008100743075436.0 x 60mm Bone Screw Fastener STOsteocentric Technologies, Inc.JDO2025-09-26
008100743075506.0 x 65mm Bone Screw Fastener STOsteocentric Technologies, Inc.JDO2025-09-26
0081007430898411 X 75mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081007430997411 X 80mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081007430998111 X 85mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081007430999811 X 90mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911000711 X 95mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911001411 X 100mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911002111 X 105mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911003811 X 110mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911004513 X 75mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911005213 X 80mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911006913 X 85mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911007613 X 90mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911008313 X 95mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911009013 X 100mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911010613 X 105mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911011313 X 110mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911012013 X 115mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911013713 X 120mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911014415 X 75mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911015115 X 80mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911016815 X 85mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911017515 X 90mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911018215 X 95mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911019915 X 100mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911020515 X 105mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
0081018911021215 X 110mm LAG FASTENEROsteocentric Technologies, Inc.JDO2025-09-22
008401944726473P Hip SystemORTHOPEDIATRICS CORP.JDO2025-06-19