FDA.reportPublic FDA data

CS Spine Frame

Primary DI
05060624120763
Brand
CS Spine Frame
Company
CARE SURGICAL LIMITED
Model
CSM 2712
Catalog number
CSM 2712
Published
2025-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BWNTable And Attachments, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWNTable And Attachments, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060624120763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060624120763050606241207635060624120763

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioner base plateA device in the form of a flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices can be attached (e.g., arch frame, thermoplastic mask, headrest, head positioner). It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
221313015
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060624129087CS Plexus Wedges (Pair)CSM2908CSM29082026-05-04
05060624128332Face Guard Cushion C-Flex925.FGC-CFLEX925.FGC-CFLEX2026-05-01
05060624123696CS Align Pro Support - Replacement PadsCSM2780CSM27802026-03-23
05060624126970CS Align Pro SupportCSM2781CSM27812026-03-23
05060624127182CS Easy Prone (170 mm) - GreyCSM2918-GCSM2918-G2026-01-26
05060624127199CS Easy Prone (170 mm) - Chest only (Grey)CSM2922-GCSM2922-G2026-01-26
05060624127342CS FlexiFin™ Stirrup Pads (Pair) – Low BMI Patients CSM3086CSM30862026-01-26
05060624127366CS Easy Prone (150 mm) - GreyCSM2699-GCSM2699-G2026-01-26
05060624127373CS Easy Prone (150 mm) - Chest only (Grey)CSM2920-GCSM2920-G2026-01-26
05060624127397CS Easy Prone (150 mm) - Pelvis Only (Grey) CSM2921-GCSM2921-G2026-01-26
05060624127403CS Easy Prone (170 mm) - Pelvis only (Grey)CSM2923-GCSM2923-G2026-01-26
05060624127458CS Easy Prone (200 mm) - GreyCSM2919-GCSM2919-G2026-01-26
05060624127465CS Easy Prone (200 mm) - Chest only (Grey)CSM2924-GCSM2924-G2026-01-26
05060624127472CS Easy Prone (200 mm) - Pelvis only (Grey)CSM2925-GCSM2925-G2026-01-26
05060624126918Pediatric Face Guard Cushion - Box of 10925.PFGC-BX10925.PFGC-BX102025-12-23
05060624126901Pediatric Face Guard Cushion - Box of 10925.PFGC-BX10925.PFGC-BX102025-12-23
05060624126697CS Fixed Blade ClampCSM3043CSM30432025-12-17
05060624126963CS FlexiFinless™ Stirrup Pads (Pair)CSM3053CSM30532025-10-31
05060624127670CS Blade Clamp Plus – EUCSM2767CSM27672025-10-14
05060624125157CS Extension Thigh Supports (Pair) - GreyCSM2744-GCSM2744-G2025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995232030NASTERIS CORPORATIONBWN2026-05-26
10381780542254MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONBWN2026-02-05
10381780542261MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONBWN2026-02-05
03701602300044ARCH - Boot SInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300051ARCH - Boot MInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300068ARCH - Boot MInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300075ARCH - Boot SInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300099Velcro Strap longInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300105PURIST - Leg positioning systemInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300112PURIST / OLH - Boot S - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300129PURIST / OLH - Boot M - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300136OLH #ERDP - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300143OLH #ERD - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300150OLH #ER - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300167OLH #BHA- BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300174OLH #ED - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300181OLH - DENYER PLUS - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300198OLH - DENYER - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300204OLH - US/EU - BInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300211POP UNIVERSALInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300228OLH #ERDPInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300235OLH #ERDInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300242OLH #ERInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300259MP XRAYCERInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300266DAA TOP 360Innovative Orthopedic Technologies AGBWN2026-01-13
03701602300273OLH #BHAInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300280OLH #BHSInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300297OLH #EDInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300303OLH - DENYER PLUSInnovative Orthopedic Technologies AGBWN2026-01-13
03701602300310OLH - DENYERInnovative Orthopedic Technologies AGBWN2026-01-13