FDA.reportPublic FDA data

CurvaFix Low Profile Instrument Set

Primary DI
10850070500637
Brand
CurvaFix Low Profile Instrument Set
Company
CURVAFIX, INC.
Model
CIS-004-LP
Catalog number
CIS-004-LP
Device description
Provided non-sterile; Ready for cleaning and steam sterilization at healthcare facility before use; reprocessed after each use.
Published
2025-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K252019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252019000CurvaFix Low Profile SystemCurvafix, Inc.2025-08-29HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850070500637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085007050063710850070500637

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
425-276-8800support@curvafix.com

Regulatory Flags#

DUNS number
039779098
Device count
1
Kit
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850070500125CurvaFix® Low Profile Implant9.5 mm x 90 mmCRS-095-090-LP2025-10-22
10850070500132CurvaFix® Low Profile Implant9.5 mm x 100 mmCRS-095-100-LP2025-10-22
10850070500149CurvaFix® Low Profile Implant9.5 mm x 110 mmCRS-095-110-LP2025-10-22
10850070500156CurvaFix® Low Profile Implant9.5 mm x 120 mmCRS-095-120-LP2025-10-22
10850070500163CurvaFix® Low Profile Implant9.5 mm x 130 mmCRS-095-130-LP2025-10-22
10850070500170CurvaFix® Low Profile Implant9.5 mm x 140 mmCRS-095-140-LP2025-10-22
10850070500187CurvaFix® Low Profile Implant9.5 mm x 150 mmCRS-095-150-LP2025-10-22
10850070500194CurvaFix® Low Profile Implant9.5 mm x 160 mmCRS-095-160-LP2025-10-22
10850070500200CurvaFix® Low Profile Implant9.5 mm x 170 mmCRS-095-170-LP2025-10-22
10850070500217CurvaFix® Low Profile Implant9.5 mm x 180 mmCRS-095-180-LP2025-10-22
10850070500224CurvaFix® Low Profile Implant9.5 mm x 190 mmCRS-095-190-LP2025-10-22
10850070500231CurvaFix® Low Profile Implant9.5 mm x 200 mmCRS-095-200-LP2025-10-22
10850070500248CurvaFix® Low Profile Implant9.5 mm x 210 mmCRS-095-210-LP2025-10-22
10850070500255CurvaFix® Low Profile Implant7.5 mm x 90 mmCRS-075-090-LP2025-10-22
10850070500262CurvaFix® Low Profile Implant7.5 mm x 100 mmCRS-075-100-LP2025-10-22
10850070500279CurvaFix® Low Profile Implant7.5 mm x 110 mmCRS-075-110-LP2025-10-22
10850070500286CurvaFix® Low Profile Implant7.5 mm x 120 mmCRS-075-120-LP2025-10-22
10850070500293CurvaFix® Low Profile Implant7.5 mm x 130 mmCRS-075-130-LP2025-10-22
10850070500309CurvaFix® Low Profile Implant7.5 mm x 140 mmCRS-075-140-LP2025-10-22
10850070500316CurvaFix® Low Profile Implant7.5 mm x 150 mmCRS-075-150-LP2025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449033393A.L.P.S. mvX™Tyber Medical, LLCHWC2026-07-23
00196449033409A.L.P.S. mvX™Tyber Medical, LLCHWC2026-07-23
00841731140395ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140401ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140418ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140425ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140432ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140449ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140456ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140463ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140470ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140487ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140494ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140500ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140517ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140524ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140531ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140548ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140555ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140562ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140593ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140609ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140616ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140623ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140630ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140647ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140654ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140661ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140678ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140685ARTEMIS FUZEVILEX LLCHWC2026-07-22