FDA.reportPublic FDA data

GENERIC Surgical Instruments

Primary DI
00841732141551
Brand
GENERIC Surgical Instruments
Company
CTL Medical Corporation
Model
106.7022
Device description
Curette, Size 2, Straight
Published
2025-06-04
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
K213641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213641000MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation2022-09-15MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732141551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732141551008417321415518417321415510841732141551

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
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
00841732168091MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87002026-08-14
00841732168107MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87042026-08-14
00841732168114MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87012026-08-14
00841732168121MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87022026-08-14
00841732168138MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87032026-08-14
00841732168527TAURUS Pedicle Screw System059.80132026-07-28
00841732169272PICASSO MIS Spinal System016.31602026-07-24
00841732169289PICASSO MIS Spinal System016.31702026-07-24
00841732169296PICASSO MIS Spinal System016.31802026-07-24
00841732169302PICASSO MIS Spinal System016.31902026-07-24
00841732169319PICASSO MIS Spinal System016.32002026-07-24
00841732163447VALEO C Spacer System91.002.40012023-09-30
00841732163454VALEO C Spacer System91.002.40022023-09-30
00841732163461VALEO C Spacer System91.002.40032023-09-30
00841732128231VALEO VBR91.009.56512023-09-27
00841732128248VALEO VBR91.009.56522023-09-27
00841732145511VALEO C+CSC with Lumen Interbody Fusion Device11.209.17072023-09-19
00841732145528VALEO C+CSC with Lumen Interbody Fusion Device11.209.17082023-09-19
00841732145535VALEO C+CSC with Lumen Interbody Fusion Device11.209.17092023-09-19
00841732145542VALEO C+CSC with Lumen Interbody Fusion Device11.209.17102023-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705034579689N/AMedos International SàrlHTF2026-09-26
10705034579696N/AMedos International SàrlHTF2026-09-26
10705034579702N/AMedos International SàrlHTF2026-09-26
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
00810238290070PRINCETONPrinceton Medical Group, Inc.HTF2026-09-22
00850088713763PRINCETONPrinceton Medical Group, Inc.HTF2026-09-22
B7684612300Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2026-06-02
B768347375900Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2025-12-12
B7684836320Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2024-08-28
B7684836410Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2024-06-05
B768347270900Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2024-05-31
B768347280300Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2024-05-31
B768347370300Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2024-05-31
B768347390300Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2024-05-31
B7684661050Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2023-04-28
B7684662050Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2023-04-28
B7684662250Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2023-04-28
B7684663050Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2023-04-28
B7684663250Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2023-04-28
B7684623200Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2023-04-10
B7684613300Buxton BioMedicalBUXTON BIOMEDICAL, INC.HTF2023-03-24