FDA.reportPublic FDA data

Steerable Guide Sleeve, Small Implant

Primary DI
10855068008577
Brand
Steerable Guide Sleeve, Small Implant
Company
CURVAFIX, INC.
Model
GSS-001
Catalog number
GSS-001
Device description
A hand-held tubular surgical device designed to be used during a CurvaFix Implant implantation procedure to facilitate the acceptance of a Steerable Guide through it.
Published
2022-12-05
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855068008577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085506800857710855068008577

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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
true
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
06932503563857Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563864Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563871Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
00810056993139corraCarlsmed, Inc.FZX2026-01-30
00810112590036MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590043MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590050MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590067MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590098MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590104MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590128MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590135MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590142MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590180MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590197MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590203MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590210MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590227MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590234MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590241MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590258MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590265MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590272MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590289MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590319MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590326MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590333MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590357MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590364MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590371MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05