FDA.reportPublic FDA data

aprevo

Primary DI
00810056990749
Brand
aprevo
Company
Carlsmed, Inc.
Model
1021
Device description
aprevo Rod Bending Template, Right
Published
2021-10-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202034000aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.2020-12-03MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810056990749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810056990749008100569907498100569907490810056990749

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117449452
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810056993146corra16202026-01-30
00810056995638corra1421.20.22026-08-17
00810056992743aprevo1098.13.22026-03-17
00810056992804aprevo1098.15.22026-03-17
00810056992866aprevo1098.17.22026-03-17
00810056992958aprevo1098.20.22026-03-17
00810056995430corra1426.18.32026-03-11
00081005699543corra1426.18.32026-02-04
00810056993092corra16102026-01-31
00810056993108corra16162026-01-30
00810056993122corra1550.27.142026-01-30
00810056993139corra15602026-01-30
00810056993153corra1550.22.122026-01-30
00810056993160corra1550.22.142026-01-30
00810056993177corra1550.22.162026-01-30
00810056993184corra1550.22.182026-01-30
00810056993191corra1550.22.202026-01-30
00810056993207corra1550.27.122026-01-30
00810056993214corra1550.27.162026-01-30
00810056993221corra1550.27.182026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982350596VOLTSynthes GmbHHWT2026-09-25
10886982350602VOLTSynthes GmbHHWT2026-09-25
10886982350619VOLTSynthes GmbHHWT2026-09-25
10886982350626VOLTSynthes GmbHHWT2026-09-25
10886982350695VOLTSynthes GmbHHWT2026-09-25
10886982350701VOLTSynthes GmbHHWT2026-09-25
10886982350718VOLTSynthes GmbHHWT2026-09-25
00840606191326PrimusSPINAL ELEMENTS, INC.HWT2026-09-22
03701313009502K-RODS.M.A.I.OHWT2026-09-22
10888857298590ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298606ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298613ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298620ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298637ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298644ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298651ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298668ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298675ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298682ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298699ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298705ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298712ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298729ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857562332K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562349K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562356K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562363K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562370K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562387K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562394K2M General InstrumentsVB Spine LLCHWT2023-09-08