Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017936978

FEI Number

3017936978

Entity Name

CARLSMED, INC.

City/State/Country

Carlsbad, CA, US

Establishment Address

1800 Aston Avenue, Suite 100, Carlsbad, CA 92008, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Carlsmed, Inc. (Owner Number: 10080208)

Owner / Operator Contact Address

1800 Aston Avenue, Suite 100, Carlsbad, CA 92008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243635

PMA Number

N/A

All Registered Proprietary Names

aprevo® anterior lumbar interbody fusion device with interfixation aprevo® Inserter aprevo® Cervical Interbody System aprevo® posterior/transforaminal lumbar interbody fusion device aprevo® anterior and lateral lumbar interbody fusion devices aprevo® anterior lumbar interbody fusion device with interfixation aprevo® Awls corra drill guide corra cervical plating system aprevo® Cervical Interbody System aprevo® transforaminal lumbar interbody fusion device aprevo® anterior lumbar interbody fusion device aprevo® lateral lumbar interbody fusion device aprevo® anterior lumbar interbody fusion device with interfixation corra drills aprevo® anterior lumbar interbody fusion device with interfixation aprevo® transforaminal lumbar interbody fusion device aprevo® transforaminal lumbar interbody fusion device aprevo® anterior lumbar interbody fusion device aprevo® lateral lumbar interbody fusion device aprevo® Digital Workflow aprevo® Digital Segmentation aprevo® transforaminal lumbar interbody fusion device aprevo® lateral lumbar interbody fusion device aprevo® anterior lumbar interbody fusion device aprevo® anterior lumbar interbody fusion device with interfixation aprevo® lateral lumbar interbody fusion device aprevo® transforaminal lumbar interbody fusion device aprevo® anterior lumbar interbody fusion device aprevo® anterior lumbar interbody fusion device aprevo® lateral lumbar interbody fusion device aprevo® transforaminal lumbar interbody fusion device aprevo® TLIF-C Articulating System aprevo® posterior/transforaminal lumbar interbody fusion device aprevo anterior lumbar fusion device with interfixation

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2022-12-06
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-07-21
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-07-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-07-21
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-07-21
HWJ	Awl	Orthopedic	Class 1	888.4540	2022-12-06
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-01-12
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-12-31
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-06-19
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-06-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-02-25
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-02-25
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2026-01-12
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-02-25
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-02-25
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-02-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-02-28
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-06-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-02-25
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-02-25
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-02-25
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-01-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-10-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-08-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-07-21
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-02-25

Official Correspondent

Mike Cordonnier

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Carlsmed, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K192492	Astura Medical, LLC	EL CAPITAN Anterior Lumber Interbody System	2020-04-21
K212498	Nexus Spine, LLC	Stable-L Standalone Lumbar Interbody System	2022-03-18
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017936978. Last updated year: 2026. Please use registration number 3017936978 when referencing this establishment in official correspondence.