FDA.reportPublic FDA data

Carbon spine frame

Primary DI
07640143930487
Brand
Carbon spine frame
Company
Schaerer Medical AG
Model
CSF
Catalog number
91600
Published
2025-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GDCTable, Operating-Room, Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640143930487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640143930487076401439304877640143930487

GMDN Terms#

Term, Definition table
TermDefinition
Spinal surgery positioning boardA device comprised of a supportive foundation and adjustable positioning elements designed to be attached to an operating table to enable correct positioning and immobilization of a patient during surgical procedures involving the spine (e.g., thoracolumbrosacral surgery, disc decompression). It supports the patient in the prone or supine position providing a close approximation to a patient's natural lumbar lordosis while facilitating reduced abdominal compression. It typically consists of a base plate/board made of durable materials (e.g., metal, carbon fibre) to which other devices are attached (e.g., intraoperative positioners, headrest, x-ray cassette). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
484713792
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640143930043Intermediate plate for Axis909512025-07-23
07640143930050Intermediate platefor Axis909522025-07-23
07640143930166Side rail adapterShort916032025-07-23
07640143930180Side rail adapterLong916042025-07-23
07640143930807Side rail (1 pcs.)for Axis905932025-07-23
07640143930852Leg plates 2-part for Axis 400-700914952025-07-23
07640143932658Head rest standard for Axis 400-700914902025-07-23
07640143930029Axis700915972025-06-18
07640143930296Hand surgery table with fixing screw909132025-06-18
07640143930005Axis500915952025-05-08
07640143930012Axis600915962025-05-08
07640143930135Carbon-fibre plate850mm906242025-05-08
07640143930173Carbon fibre-plate850mm906252025-05-08
07640143930654Carbon-fibre plate1400mm906272025-05-08
07640143930906Radial setting clampwith fixing screw905062025-05-08
07640143932450Infusion Polewith fixing clamp905002025-05-08
07640143932610Anaesthesia screenrigid903212025-05-08
07640143930708Schaerer Medical90913909132023-07-03
07640143932412Schaerer Medical92410924102023-07-03
07640143933044Schaerer Medical91451914512023-07-03

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Primary DI, Brand, Company table
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00810050245562NADOMICO MED-DEVICE, LLCGDC2025-09-24
00724995244880NASTERIS CORPORATIONGDC2025-05-05
00724995244965NASTERIS CORPORATIONGDC2025-05-05
00724995245030CMAX XRAY Remote ControlSTERIS CORPORATIONGDC2025-05-05
00887761966673Carbon Pelvic systemBaxter Medical Systems GmbH + Co. KGGDC2025-01-17
00857534006721Headboard AssemblyIMRIS Imaging, Inc.GDC2024-10-04
00887761967977Hillrom™Baxter Medical Systems GmbH + Co. KGGDC2024-02-22
00887761967984Hillrom™Baxter Medical Systems GmbH + Co. KGGDC2024-02-22
00887761967342Orthopedic ExtensionBaxter Medical Systems GmbH + Co. KGGDC2023-01-17
00887761967717Control UnitsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967731Back SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967748Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967762Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967793Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967809Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967816Back SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967823Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967830Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967847Leg SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967854Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967861Head SectionsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967878PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967892PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967908PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967922PadsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761968660Control UnitsBaxter Medical Systems GmbH + Co. KGGDC2023-01-03
00887761967526TS 7000Baxter Medical Systems GmbH + Co. KGGDC2022-12-27
00887761967533TS 7000Baxter Medical Systems GmbH + Co. KGGDC2022-12-27