FDA.reportPublic FDA data

HammerFiX

Primary DI
00842078100004
Brand
HammerFiX
Company
EXTREMITY MEDICAL, LLC
Model
132-00050-S
Device description
HammerFiX Sizing Key (Sterile Pack)
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K133636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133636000EXTREMITY MEDICAL HAMMERTOE DEVICEExtremity Medical, LLC2014-03-28HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842078100004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842078100004008420781000048420781000040842078100004

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, single-useA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.

Regulatory Flags#

DUNS number
832720358
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842078100011HammerFiX132-02800-S2026-10-29
00842078100028HammerFiX132-03400-S2026-10-29
00842078100035HammerFiX132-04000-S2026-10-29
00842078100127HammerFiX132-000112026-10-29
00842078100134HammerFiX132-000142026-10-29
00842078100141HammerFiX132-000162026-10-29
00842078100219HammerFiX132-001112026-10-29
00842078100295IO FiX101-000042026-10-29
00842078100318XMCP101-000062026-10-29
00842078100363IO FiX101-000112026-10-29
00842078100370IO FiX101-000122026-10-29
00842078100387IO FiX101-000132026-10-29
00842078100479IO FiX101-000222026-10-29
00842078100486XMCP101-000232026-10-29
00842078101773XMCP102-000022026-10-29
00842078101889Jones Union102-000332026-10-29
00842078102794IO FiX118-000042026-10-29
00842078102800IO FiX118-000052026-10-29
00842078102817IO FiX118-000062026-10-29
00842078103197IO FiX 2.0118-020302026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
20810152101678DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13