FDA.reportPublic FDA data

Lock Activator

Primary DI
10855068008423
Brand
Lock Activator
Company
CURVAFIX, INC.
Model
CLA-001
Catalog number
CLA-001
Device description
Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture.
Published
2022-06-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855068008423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085506800842310855068008423

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01