FDA.reportPublic FDA data

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS

Primary DI
05055662934090
Brand
ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS201526
Catalog number
OS201526
Device description
REAMING ROD 2.6MM X 900MM, OLIVE
Published
2017-06-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110895000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110895000ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESISOrtho Solutions Limited2011-12-19HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055662934090PackageGS12In Commercial Distribution
05055662934106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055662934090050556629340905055662934090
05055662934106050556629341065055662934106

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05055662971392ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353104-SOS353104-S2026-04-09
05055662971408ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS353113-SOS353113-S2026-04-09
05055662971415ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355055-SOS355055-S2026-04-09
05055662971422ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355060-SOS355060-S2026-04-09
05055662971439ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355065-SOS355065-S2026-04-09
05055662971446ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS355070-SOS355070-S2026-04-09
05055662971453ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356045-SOS356045-S2026-04-09
05055662971460ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356050-SOS356050-S2026-04-09
05055662971477ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356055-SOS356055-S2026-04-09
05055662971484ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356060-SOS356060-S2026-04-09
05055662971491ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356065-SOS356065-S2026-04-09
05055662971507ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356070-SOS356070-S2026-04-09
05055662971521ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356080-SOS356080-S2026-04-09
05055662971538ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356115-SOS356115-S2026-04-09
05055662971545ORTHO SOLUTIONS SUCCESSION AFN SYSTEMOS356120-SOS356120-S2026-04-09
05055662971552Volition™ Plating SystemOS731019L-NSOS731019L-NS2026-03-04
05055662971569Volition™ Plating SystemOS731019R-NSOS731019R-NS2026-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01