FDA.reportPublic FDA data

GENERIC Surgical Instruments

Primary DI
00841732124691
Brand
GENERIC Surgical Instruments
Company
CTL Medical Corporation
Model
103.7050
Device description
Curette, 10.5x8, Bayonet, Serrated, Forward Angle
Published
2025-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTFCurette
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121567000ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEMAccel Spine2012-09-26MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732124691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732124691008417321246918417321246910841732124691

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(214)545-5820schedule@ctlmed.com

Regulatory Flags#

DUNS number
080138504
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841732155671VALEO II PL OL Interbody Fusion System12.301.10122023-09-27
00841732155688VALEO II PL OL Interbody Fusion System12.301.10132023-09-27
00841732155695VALEO II PL OL Interbody Fusion System12.301.10152023-09-27
00841732155701VALEO II PL OL Interbody Fusion System12.301.10142023-09-27
00841732155718VALEO II PL OL Interbody Fusion System12.301.10162023-09-27
00841732155725VALEO II PL OL Interbody Fusion System12.301.15082023-09-27
00841732155732VALEO II PL OL Interbody Fusion System12.301.15092023-09-27
00841732155749VALEO II PL OL Interbody Fusion System12.301.15102023-09-27
00841732155756VALEO II PL OL Interbody Fusion System12.301.15112023-09-27
00841732155763VALEO II PL OL Interbody Fusion System12.301.15122023-09-27
00841732155770VALEO II PL OL Interbody Fusion System12.301.15132023-09-27
00841732155787VALEO II PL OL Interbody Fusion System12.301.15142023-09-27
00841732155794VALEO II PL OL Interbody Fusion System12.301.15152023-09-27
00841732155800VALEO II PL OL Interbody Fusion System12.301.15162023-09-27
00841732156135VALEO II PL OL Interbody Fusion System12.301.20072023-09-27
00841732156142VALEO II PL OL Interbody Fusion System12.301.20082023-09-27
00841732156159VALEO II PL OL Interbody Fusion System12.301.20092023-09-27
00841732156166VALEO II PL OL Interbody Fusion System12.301.20102023-09-27
00841732156173VALEO II PL OL Interbody Fusion System12.301.20112023-09-27
00841732156180VALEO II PL OL Interbody Fusion System12.301.20122023-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043966040N/ATDM Co., Ltd.MAX2026-06-08
08800043966057N/ATDM Co., Ltd.MAX2026-06-08
08800043966064N/ATDM Co., Ltd.MAX2026-06-08
08800043966071N/ATDM Co., Ltd.MAX2026-06-08
08800043966088N/ATDM Co., Ltd.MAX2026-06-08
08800043966095N/ATDM Co., Ltd.MAX2026-06-08
08800043966101N/ATDM Co., Ltd.MAX2026-06-08
08800043966118N/ATDM Co., Ltd.MAX2026-06-08
08800043966125N/ATDM Co., Ltd.MAX2026-06-08
08800043966132N/ATDM Co., Ltd.MAX2026-06-08
08800043966149N/ATDM Co., Ltd.MAX2026-06-08
08800043966156N/ATDM Co., Ltd.MAX2026-06-08
08800043966163N/ATDM Co., Ltd.MAX2026-06-08
08800043966170N/ATDM Co., Ltd.MAX2026-06-08
08800043966187N/ATDM Co., Ltd.MAX2026-06-08
08800043966194N/ATDM Co., Ltd.MAX2026-06-08
08800043966200N/ATDM Co., Ltd.MAX2026-06-08
08800043966217N/ATDM Co., Ltd.MAX2026-06-08
08800043966224N/ATDM Co., Ltd.MAX2026-06-08
08800043966231N/ATDM Co., Ltd.MAX2026-06-08
08800043966248N/ATDM Co., Ltd.MAX2026-06-08
08800043966255N/ATDM Co., Ltd.MAX2026-06-08
08800043966262N/ATDM Co., Ltd.MAX2026-06-08
08800043966279N/ATDM Co., Ltd.MAX2026-06-08
08800043966286N/ATDM Co., Ltd.MAX2026-06-08
08800043966293N/ATDM Co., Ltd.MAX2026-06-08
08800043966309N/ATDM Co., Ltd.MAX2026-06-08
08800043966316N/ATDM Co., Ltd.MAX2026-06-08
08800043966323N/ATDM Co., Ltd.MAX2026-06-08
08800043966330N/ATDM Co., Ltd.MAX2026-06-08