FDA.report

ORTHO SOLUTIONS ULTOS PLATING SYSTEM

Primary DI
05055662909159
Brand
ORTHO SOLUTIONS ULTOS PLATING SYSTEM
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS326945
Catalog number
OS326945
Device description
3.5MM X 45MM CANNULATED SCREW SELF DRILL/TAP
Published
2016-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HRSPlate, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055662909159PackageGS12In Commercial Distribution
05055662909166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055662909159050556629091595055662909159
05055662909166050556629091665055662909166

GMDN Terms

TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods

Method

Contacts

PhoneEmail
+441621843599quality@orthosol.com

Regulatory Flags

DUNS number
218648211
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

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05055662970531ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353502-NSOS353502-NS2025-08-15
05055662970548ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353503-NSOS353503-NS2025-08-15
05055662970555ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353504-NSOS353504-NS2025-08-15
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