FDA.reportPublic FDA data

MetaFore

Primary DI
00842078136737
Brand
MetaFore
Company
EXTREMITY MEDICAL, LLC
Model
171-25118-S
Device description
Fully Threaded Screw Ø2.5 X 18, Sterile
Published
2026-01-22
Public version status
New
Distribution status
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
K250536000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250536000MetaFore Small Screw SystemExtremity Medical, LLC2025-10-08HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842078136737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842078136737008420781367378420781367370842078136737

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832720358
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
00842078125724Carilaginator168-050102026-06-09
00842078125748Carilaginator168-050202026-06-09
00842078130261Carilaginator170-021412026-06-09
00842078130315Carilaginator170-021402026-06-09
00842078130452Carilaginator170-012512026-06-09
00842078130490Carilaginator170-012502026-06-09
00842078130537Carilaginator170-000112026-06-09
00842078134054Carilaginator168-05010-S2026-06-09
00842078134061Carilaginator168-05020-S2026-06-09
00842078134078Carilaginator170-00011-S2026-06-09
00842078134085Carilaginator170-01250-S2026-06-09
00842078134092Carilaginator170-01251-S2026-06-09
00842078134108Carilaginator170-02140-S2026-06-09
00842078134115Carilaginator170-02141-S2026-06-09
00842078136553MetaFore171-25012-S2026-01-22
00842078136560MetaFore171-25014-S2026-01-22
00842078136577MetaFore171-25016-S2026-01-22
00842078136584MetaFore171-25018-S2026-01-22
00842078136591MetaFore171-25020-S2026-01-22
00842078136607MetaFore171-25022-S2026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08057717550009BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550016BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550023BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550030BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550047BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550061BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550290BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550313BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550368BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550382BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550405BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550429BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550443BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550467BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550481BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09