Secure-Lock

Primary DI
05060267132000
Brand
Secure-Lock
Company
XIROS LTD
Model
102-1377
Published
2022-07-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSuture, Nonabsorbable, Synthetic, Polyethylene
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220906000SECURE-LOCKXiros, Ltd.2022-07-22HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060267132000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060267132000050602671320005060267132000

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
+4401132387202enquiries@xiros.co.uk

Regulatory Flags#

DUNS number
228209805
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060267134547FORCECORDMCRD55802026-07-06
05060267134554FORCECORD Passing ProbeMPDP30202026-07-06
05060267134561FORCECORD ImplantMWEB55802026-07-06
05060267131812Poly-Tape 30mm x 800mm102-1083n/a2023-07-03
05060267132499Poly-Tape 5 mm x 800 mm 102-1086102-10862022-10-14
05060267132505Poly-Tape 7 mm x 800 mm 102-1087102-10872022-10-14
05060267132512Poly-Tape 10 mm x 800 mm 102-1080102-10802022-10-14
05060267132529Poly-Tape 15 mm x 800 mm 102-1081102-10812022-10-14
05060267132536Poly-Tape 20 mm x 800 mm 102-1082102-10822022-10-14
05060267132543Infinity-Lock 3102-1100102-11002022-10-14
05060267132550Infinity-Lock 5102-1101102-11012022-10-14
05060267132567Infinity-Lock 7 102-1102102-11022022-10-14
05060267131928Infinity-Lock 3102-1100102-11002020-06-04
05060267131935Infinity-Lock 5102-1101102-11012020-06-04
05060267130365Poly-Tape 10 mm x 500 mm102-1010n/a2015-10-09
05060267130372Poly-Tape 15 mm x 500 mm102-1011n/a2015-10-09
05060267130389Poly-Tape 20 mm x 500 mm102-1012n/a2015-10-09
05060267130402Poly-Tape 30 mm x 500 mm102-1013n/a2015-10-09
05060267130433Poly-Tape (dia. 5 mm) x 500 mm (TUBE)102-1040n/a2015-10-09
05060267130471Poly-Tape 10 mm x 800 mm102-1080n/a2015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05055662968538Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHTY2026-10-16
09353903004240FO NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-10-12
09353903004257FO NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-10-12
20845854655501Argo KnotlessConmed CorporationGAT2026-09-25
20845854655518Argo KnotlessConmed CorporationGAT2026-09-25
14026704420305DEKNATELTELEFLEX INCORPORATEDGAT2026-09-21
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-06-24
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTY2024-09-19
B562PK301ELB1600K-WireWishbone Medical, Inc.HTY2023-03-16
B562PK301ELB2000K-WireWishbone Medical, Inc.HTY2023-03-16
B562PK301EXT1250K-WireWishbone Medical, Inc.HTY2023-03-16
B56213904001220S00WishBone K-Wire SystemWishbone Medical, Inc.HTY2022-07-18
B56213904001220S10WishBone K-Wire SystemWishbone Medical, Inc.HTY2022-07-18
B56213904001620S00WishBone K-Wire SystemWishbone Medical, Inc.HTY2022-07-18
B56213904001620S10WishBone K-Wire SystemWishbone Medical, Inc.HTY2022-07-18
B56213904002020S00WishBone K-Wire SystemWishbone Medical, Inc.HTY2022-07-18
B56213904002020S10WishBone K-Wire SystemWishbone Medical, Inc.HTY2022-07-18
B56213904002520S00WishBone K-Wire SystemWishbone Medical, Inc.HTY2022-07-18
B56213904002520S10WishBone K-Wire SystemWishbone Medical, Inc.HTY2022-07-18
14026704738028DEKNATELTELEFLEX INCORPORATEDGAT2021-08-03
34026704592242DEKNATELTELEFLEX INCORPORATEDGAT2021-01-22
14026704427021DEKNATELTELEFLEX INCORPORATEDGAT2020-12-18
34026704422228DEKNATELTELEFLEX INCORPORATEDGAT2020-12-18
34026704426073DEKNATELTELEFLEX INCORPORATEDGAT2020-12-18
B562PKKWELB0WishBone K-Wire SystemWishbone Medical, Inc.HTY2020-12-02
B562PKKWEXT0WishBone K-Wire SystemWishbone Medical, Inc.HTY2020-12-02
10381780357490K-FIX®NEWDEALHTY2020-11-23
14026704647825DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27