FDA.reportPublic FDA data

corra

Primary DI
00810056993092
Brand
corra
Company
Carlsmed, Inc.
Model
1610
Device description
corra™, Cervical Plate Alignment Tool
Published
2026-01-31
Public version status
New
Distribution status
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252611000aprevo® cervical plating systemCarlsmed, Inc.2025-12-22KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810056993092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810056993092008100569930928100569930920810056993092

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810056993108corra16162026-01-30
00810056993122corra1550.27.142026-01-30
00810056993139corra15602026-01-30
00810056993146corra16202026-01-30
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
00810056993238corra1550.27.202026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606168533SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168557SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168571SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168588SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168595SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168601SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168618SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168625SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168632SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168656SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168663SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168687SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168694SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168717SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168748SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168755SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168779SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168786SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168809SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168816SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168830SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168847SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168861SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168878SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168892SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168908SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168922SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606168939SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606169769SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27
00840606169776SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-08-27