FDA.report

aprevo

Primary DI
00810056991852
Brand
aprevo
Company
Carlsmed, Inc.
Model
1300
Device description
aprevo® Inserter, TLIF-C Articulating
Published
2024-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K241019000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241019000aprevo® TLIF-C Articulating SystemCarlsmed2024-07-09MAX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810056991852PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic inorganic implant inserter/extractor, single-useA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
117449452
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00810056993221corra1550.27.182026-01-30
00810056993238corra1550.27.202026-01-30

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06009527200096TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
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06009527200119TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
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06009527200218TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200225TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
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