FDA.reportPublic FDA data

LARGE CANNULATED SCREWS

Primary DI
23596010291121
Brand
LARGE CANNULATED SCREWS
Company
Smith & Nephew, Inc.
Model
71102000
Catalog number
71102000
Device description
TITANIUM WASHER-12.7MM OUTER DIAMETER 6.5MM INNER DIAMETER
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060736000SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWSSmith & Nephew, Inc.2006-04-18HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23596010291121PackageGS16In Commercial Distribution
03596010291127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2359601029112123596010291121
03596010291127035960102911273596010291127

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, sterileA sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods#

Method table
Method

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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188131615CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131639CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131653CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131721CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
10886982342508VOLTSynthes GmbHHWC2026-09-25
10886982342515VOLTSynthes GmbHHWC2026-09-25
10886982342522VOLTSynthes GmbHHWC2026-09-25
10886982342539VOLTSynthes GmbHHWC2026-09-25
10886982342546VOLTSynthes GmbHHWC2026-09-25
10886982342553VOLTSynthes GmbHHWC2026-09-25
10886982342560VOLTSynthes GmbHHWC2026-09-25
10886982342577VOLTSynthes GmbHHWC2026-09-25
10886982342584VOLTSynthes GmbHHWC2026-09-25
10886982342591VOLTSynthes GmbHHWC2026-09-25