FDA.reportPublic FDA data

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
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
05060267130488Poly-Tape 15 mm x 800 mm102-1081n/a2015-10-09
05060267130495Poly-Tape 20 mm x 800 mm102-1082n/a2015-10-09
05060267130501Poly-Tape 30 mm x 800 mm102-1083n/a2015-10-09

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Primary DI, Brand, Company table
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07630894830891APTUSMedartis AGHTY2026-06-01
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07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHGAT2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHHTY2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHHTY2025-10-01
07630037863977APTUSMedartis AGHTY2025-07-31
07630037863984APTUSMedartis AGHTY2025-07-31
07630037864011APTUSMedartis AGHTY2025-04-08
07630037864264APTUSMedartis AGHTY2025-04-08
07613327084191STEINMANNStryker GmbHHTY2025-01-09
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTY2024-09-19
07649990202075SupraFuser GeneratorSurgical Fusion Technologies GmbHHTY2024-04-12
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHGAT2024-04-12
07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202297Guide S-PI / W5.0Surgical Fusion Technologies GmbHHTY2024-04-12