FDA.reportPublic FDA data

OrthoSolutions 'System26' Bone Screws

Primary DI
05055662956108
Brand
OrthoSolutions 'System26' Bone Screws
Company
ORTHO SOLUTIONS HOLDINGS LIMITED
Model
OS900037-NS
Catalog number
OS900037-NS
Device description
DRILL FOR 3.0MM SCREW CALIBRATED CANNULATED AO QC
Published
2017-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXYBrace, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXYBrace, DrillOrthopedic1

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
05055662956108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055662956108050556629561085055662956108

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-use, sterileA sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use 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
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
10885862605764EPICExactech, Inc.HXY2026-04-28
05055662970593ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-08-14
05055662971293Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971309Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971316Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971323Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
00889024682399PSN TM TIB DRILL GDEZimmer, Inc.HXY2025-01-13
00810027271594Citrelock ACL Tibial Drill Guide, Flat HookAcuitive Technologies, Inc.HXY2024-12-03
00191083044569Meniscus Allograft Transplantation (MAT)Rti Surgical, Inc.HXY2024-10-14
04049197096812RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-16
04049197096744RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-15
04026575534678LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04026575534739LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04049197187848RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-06-28
00840183516031BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
00840183516048BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
M73910290060TransFasten-LSF, Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290130TransFasten - LSF, Sharp Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290140TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290150TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 457mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290170TransFasten - LSF, Open-Ended Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290180TransFasten - LSF, Parallel GuideCAPTIVA SPINE, INC.HXY2024-04-25
05055662969825COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969832COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969849COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969856COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969863COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969870COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
M7392030002104-Hole Drill GuideCAPTIVA SPINE, INC.HXY2024-03-11
08033860019105BIOPSYBELLBIOPSYBELL SRLHXY2024-02-23