FDA.reportPublic FDA data

CMC Cable Fix

Primary DI
10815375021058
Brand
CMC Cable Fix
Company
Restore Surgical LLC
Model
CM9000
Published
2015-10-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTNWasher, Bolt Nut

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815375021058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081537502105810815375021058

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
792932626
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815375021812ToeTac™ Hammertoe Fixation System, SmallHT-000012015-10-17
10815375021829ToeTac™ Hammertoe Fixation System, MediumHT-00002 2015-10-17
10815375021836ToeTac™ Hammertoe Fixation System, LargeHT-00003 2015-10-17
10815375021065Sub-Talar LokST50072015-10-17
10815375021072Sub-Talar LokST50082015-10-17
10815375021089Sub-Talar LokST50092015-10-17
10815375021096Sub-Talar LokST50102015-10-17
10815375021102Sub-Talar LokST50112015-10-17
10815375020013Mini Cannulated Titanium Headed and Headless Screw SetIC25102015-10-17
10815375020020Mini Cannulated Titanium Headed and Headless Screw SetIC25122015-10-17
10815375020037Mini Cannulated Titanium Headed and Headless Screw SetIC25142015-10-17
10815375020044Mini Cannulated Titanium Headed and Headless Screw SetIC25162015-10-17
10815375020051Mini Cannulated Titanium Headed and Headless Screw SetIC25182015-10-17
10815375020068Mini Cannulated Titanium Headed and Headless Screw SetIC25202015-10-17
10815375020075Mini Cannulated Titanium Headed and Headless Screw SetIC25222015-10-17
10815375020082Mini Cannulated Titanium Headed and Headless Screw SetIC25242015-10-17
10815375020099Mini Cannulated Titanium Headed and Headless Screw SetIC25262015-10-17
10815375020105Mini Cannulated Titanium Headed and Headless Screw SetIC25282015-10-17
10815375020112Mini Cannulated Titanium Headed and Headless Screw SetIC25302015-10-17
10815375020129Mini Cannulated Titanium Headed and Headless Screw SetIC25322015-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543023PC Fix Washer TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543085PC Fix Thoracic Plate 95mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543092PC Fix 3.2mm Drill Brad Point QCChest Wall Innovations, Inc.HTN2026-06-01
00850080543108PC Fix Graphic CaseChest Wall Innovations, Inc.HTN2026-06-01
00850080543115PC Fix Clamp/Drill Guide TopChest Wall Innovations, Inc.HTN2026-06-01
00850080543122PC Fix Clamp/Drill Guide BottomChest Wall Innovations, Inc.HTN2026-06-01
00850080543139PC Fix Compression ClampChest Wall Innovations, Inc.HTN2026-06-01
00850080543146PC Fix 3.2mm Drill Dental LatchChest Wall Innovations, Inc.HTN2026-06-01
00850080543184PC Fix Implant CaddyChest Wall Innovations, Inc.HTN2026-06-01
07901125602533Expert KnotlessGM DOS REIS INDUSTRIA E COMERCIO LTDAHTN2026-05-28
00888867251960Arthrex®ARTHREX, INC.HTN2017-11-28
00888867251939Arthrex®ARTHREX, INC.HTN2017-02-15
07613327075830ASNISStryker GmbHHTN2015-11-11
07613327076189ASNISStryker GmbHHTN2015-11-11
07613327076301ASNISStryker GmbHHTN2015-11-11
07613327076554ASNISStryker GmbHHTN2015-11-11
07613327076721ASNISStryker GmbHHTN2015-11-11
07613327076929ASNISStryker GmbHHTN2015-11-11
07613327077049ASNISStryker GmbHHTN2015-11-11
07613327073737VARIAXStryker GmbHHTN2015-09-30
07613327073768VARIAXStryker GmbHHTN2015-09-30
07613327073799VARIAXStryker GmbHHTN2015-09-30
07613327073812VARIAXStryker GmbHHTN2015-09-30