FDA.reportPublic FDA data

STORM NON STERILE operating kit

Primary DI
05060309870297
Brand
STORM NON STERILE operating kit
Company
METAPHYSIS LLP
Model
1-10-0
Catalog number
1-10-0
Device description
NON STERILE STORM OPERATING KIT: Pack of 5
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061607000STORM OPERATING KIT, MODEL 1-10-0Intelligent Orthopaedics, Ltd.2006-07-18HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060309870297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060309870297050603098702975060309870297

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4408458004405info@io-uk.com
+448448004405info@io-uk.com
+448448004405info@metaohysis.co.uk

Regulatory Flags#

DUNS number
219570490
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060309870433STORM1-10-10W1-10-10W2023-05-04
05060309872000IOS2-0-0L2016-09-23
05060309872017IOS2-0-0S2016-09-23
05060309870013STORM Sterile Operating Kit1-10-102016-09-23
5060309870020STORM Sterile Operating Kit1-10-102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606651Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606668Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606675Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606682Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606699Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606705Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606712Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606729Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606736Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606743Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606750Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606767Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
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07899258606781Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606798Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
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07899258606828Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606835Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606842Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
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07899258606866Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
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