FDA.reportPublic FDA data

GENERIC Surgical Instruments

Primary DI
00841732124707
Brand
GENERIC Surgical Instruments
Company
CTL Medical Corporation
Model
103.7051
Device description
Curette, 10.5x8, Bayonet, Serrated, Left 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
00841732124707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732124707008417321247078417321247070841732124707

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@ctlamedica.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
00841732168268VALEO II LL Interbody Fusion System91.020.22082025-06-30
00841732168275VALEO II LL Interbody Fusion System91.020.22102025-06-30
00841732168282VALEO II LL Interbody Fusion System91.020.22142025-06-30
00841732167377VALEO II PL OL Interbody Fusion System11.113.46132025-01-23
00841732167384VALEO II PL OL Interbody Fusion System11.113.48152025-01-23
00841732167339GENERIC Surgical Instruments31-5500-0022024-12-11
00841732141186VALEO II PL OL Interbody Fusion System91.000.90092024-11-01
00841732158658Valeo II LL110-3232024-11-01
00841732158665Valeo II LL110-3242024-11-01
00841732158672Valeo II LL110-3292024-11-01
00841732165236VALEO II LL Interbody Fusion System91.020.12002024-11-01
00841732166219VALEO II PL OL Interbody Fusion System11.113.47152024-11-01
00841732166820VALEO II LL Interbody Fusion System91.020.10012024-11-01
00841732167322VALEO II LL Interbody Fusion System91.020.10992024-11-01
00841732144361VALEO II C Interbody Fusion System12.600.16102023-09-27
00841732144378VALEO II C Interbody Fusion System12.600.16052023-09-27
00841732145610VALEO II C Interbody Fusion System12.600.10052023-09-27
00841732145627VALEO II C Interbody Fusion System12.600.16062023-09-27
00841732145634VALEO II C Interbody Fusion System12.600.16082023-09-27
00841732145641VALEO II C Interbody Fusion System12.600.20052023-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840283403460LumiVy™VY SPINE LLCMAX2026-06-05
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02