FDA.reportPublic FDA data

Nextra Hammertoe Correction System

Primary DI
00817701020059
Brand
Nextra Hammertoe Correction System
Company
Medartis Inc.
Model
NX-3532K-SC
Device description
3.5 Middle 3.2 Proximal Saw Cut
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
K122031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122031000NEXTRA TI HAMMERTOE CORRECTION SYSTEMNextremity Solutions, LLC2012-10-09HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817701020059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817701020059008177010200598177010200590817701020059

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
192756786
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00810082891010Stratum AnkleSALS5026NS2023-05-26
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
00817701020066Re+Line Bunion Correction SystemRS-20615K2016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867627840Arthrex®ARTHREX, INC.HWC2026-10-07
00888867627857Arthrex®ARTHREX, INC.HWC2026-10-07
00888867627864Arthrex®ARTHREX, INC.HWC2026-10-07
03700569633943NANEWCLIP TECHNICSHWC2026-10-01
03700569633967NANEWCLIP TECHNICSHWC2026-10-01
03700569633981NANEWCLIP TECHNICSHWC2026-10-01
03700569634001NANEWCLIP TECHNICSHWC2026-10-01
03700569634025NANEWCLIP TECHNICSHWC2026-10-01
03700569634049NANEWCLIP TECHNICSHWC2026-10-01
03700569634063NANEWCLIP TECHNICSHWC2026-10-01
08057717550535BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550542BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550566BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550580BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550597BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550610BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550627BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550641BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550665BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550689BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550702BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550726BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550740BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550764BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550788BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
10806378125997ACUMEDAcumed LLCHWC2025-12-08
10806378126000ACUMEDAcumed LLCHWC2025-12-08
10806378126017ACUMEDAcumed LLCHWC2025-12-08
10806378126024ACUMEDAcumed LLCHWC2025-12-08
10806378126031ACUMEDAcumed LLCHWC2025-12-08