FDA.reportPublic FDA data

GENERIC Surgical Instruments

Primary DI
00841732141544
Brand
GENERIC Surgical Instruments
Company
CTL Medical Corporation
Model
106.7016
Device description
Osteotome, Straight, 12mm
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
HWMOsteotome
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, 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
00841732141544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732141544008417321415448417321415440841732141544

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
00841732169371TAURUS LX Pedicle Screw System159.72512026-11-04
00841732169258MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation113.75132026-11-02
00841732169265MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation113.75142026-11-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437589MillenniumAvalign Technologies, Inc.HWM2026-11-04
08809974816141Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWM2026-11-03
00840329838836BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-10-30
08809974858424Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858431Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858448Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858455Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858462Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858479Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858486Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858493Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858509Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858516Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858523Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858530Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858547Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858554Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858561Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858578Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858585Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858592Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858608Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858615Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858622Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858639Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858646Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858653Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858660Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858677Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858684Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19