FDA.reportPublic FDA data

Stratum Ankle

Primary DI
00810082891010
Brand
Stratum Ankle
Company
Medartis Inc.
Model
SALS5026NS
Device description
Stratum Ankle Locking Screw Non-Sterile 5.0mmX26mm
Published
2023-05-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K212640000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212640000Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.2021-11-18HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810082891010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810082891010008100828910108100828910100810082891010

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
192756786
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810082892901Stratum AnkleSAPTTCSMLT2023-06-01
00810082891409Stratum AnkleSANLS3542S2023-05-31
00810082891454Stratum AnkleSANLS3552S2023-05-31
00810082891485Stratum AnkleSANLS3558S2023-05-31
00810082891508Stratum AnkleSANLS3562S2023-05-31
00810082891546Stratum AnkleSANLS3570S2023-05-31
00810082891584Stratum AnkleSANLS3516NS2023-05-31
00810082890341Stratum AnkleSALS3516NS2023-05-26
00810082890433Stratum AnkleSALS3534NS2023-05-26
00810082890778Stratum AnkleSALS5040S2023-05-26
00810082890846Stratum AnkleSALS5054S2023-05-26
00810082890921Stratum AnkleSALS5070S2023-05-26
00810082891034Stratum AnkleSALS5030NS2023-05-26
00810082896817Stratum AnkleSANLS3580NS2023-05-26
00810082896848Stratum AnkleSANLS5076S2023-05-26
00810082896855Stratum AnkleSANLS5078S2023-05-26
00817701027553Stratum RSSTRM-NL-2412RS-ST2020-11-10
00817701027690Stratum RSSTRM-NL-2440RS-ST2020-11-10
00817701020059Nextra Hammertoe Correction SystemNX-3532K-SC2016-09-26
00817701020066Re+Line Bunion Correction SystemRS-20615K2016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078100004HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100011HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100028HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100035HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
20810152101418DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101425DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101432DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101449DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101456DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101463DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101470DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101487DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101494DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101500DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101517DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101524DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101531DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101548DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101555DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101562DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101579DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101586DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101593DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101609DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101616DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101623DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101630DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101647DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101654DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101661DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13