FDA.reportPublic FDA data

OrthoSolutions 'System26' Bone Screws

Primary DI
05055662956672
Brand
OrthoSolutions 'System26' Bone Screws
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS900077-NS
Catalog number
OS900077-NS
Device description
SCARF CLAMP
Published
2017-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163489000OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited2017-03-08HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055662956672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055662956672050556629566725055662956672

GMDN Terms#

Term, Definition table
TermDefinition
Bone holding forcepsA surgical instrument designed to grasp and hold a bone during a surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+441621843599quality@orthosol.com

Regulatory Flags#

DUNS number
218648211
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055662922622Volition™ Plating SystemOS900091-NSOS900091-NS2026-10-16
05055662966855Volition™ Plating SystemOS720000A-NSOS720000A-NS2026-10-16
05055662966862Volition™ Plating SystemOS720000B-NSOS720000B-NS2026-10-16
05055662968538Volition™ Plating SystemOS740224-NSOS740224-NS2026-10-16
05055662969641ORTHO SOLUTIONS VOLITION PLATING SYSTEMOS720012OS720012-NS2023-10-31
05055662969474ORTHO SOLUTIONS VOLITION PLATING SYSTEMOS733114LOS733114L-NS2023-03-17
05055662976649Volition™ Plating SystemOS731052R-NSOS731052R-NS2026-10-06
05055662976656Volition™ Plating SystemOS731052L-NSOS731052L-NS2026-10-06
05055662976663Volition™ Plating SystemOS731043-NSOS731043-NS2026-10-06
05055662976670Volition™ Plating SystemOS731022R-NSOS731022R-NS2026-10-06
05055662976687Volition™ Plating SystemOS731022L-NSOS731022L-NS2026-10-06
05055662963489Volition™ Plating SystemOS731051R-NSOS731051R-NS2021-06-25
05055662963496Volition™ Plating SystemOS731051L-NSOS731051L-NS2021-06-25
05055662971057ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353017-NSOS353017-NS2025-08-15
05055662970890ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355038-SOS355038-S2026-07-10
05055662971514ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356075-SOS356075-S2026-07-10
05055662968545OrthoSolutions 'System26' Bone ScrewsOS900106-NSOS900106-NS2026-06-24
05055662971361ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353018-NSOS353018-NS2026-04-09
05055662971378ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353103-SOS353103-S2026-04-09
05055662971385ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353103L-SOS353103L-S2026-04-09

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