FDA.reportPublic FDA data

CMI Spine Frame Head Foam Supports (12 Pack)

Primary DI
00810105030730
Brand
CMI Spine Frame Head Foam Supports (12 Pack)
Company
COMPOSITE MANUFACTURING, INC.
Model
4-0009-203
Device description
Pack of Head Foam Supports for CMI Spine Frame.
Published
2024-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00810105030730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810105030730008101050307308101050307300810105030730

GMDN Terms#

Term, Definition table
TermDefinition
Traction table, manualA mobile, manually-operated, table designed to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a mechanical altering of the table surface geometry. The surface typically consists of sections that can be raised and lowered to manipulate the curvature of the patient?s spine whilst he/she lies in a supine position. Interchangeable traction devices such as head halters, pelvic belts, traction boots, and a traction unit may be used with this table. It is typically used in a healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
947090650
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810105030785"55"" Imaging Extension, Kit"3-2005-009OZ 75677752025-03-03
00810105030631Skytron Split Leg4-030-702024-03-22
00810105030648"Skytron Split Leg Pad Set 2"""4-030-70-2S2024-03-22
00810105030655"Skytron Split Leg Pad Set 3"""4-030-70-3S2024-03-22
00810105030662"Skytron Split Leg Pad Set 4"""4-030-70-4S2024-03-22
00810105030679"Skytron Split Leg Pad Set 5"""4-030-70-5S2024-03-22
00810105030006Orthopedic Fracture Attachment Kit, Berchtold3-1000-001OZ 75317752021-06-14
00810105030013Euro Orthopedic Fracture Attachment3-2006-001OZ 75317042020-03-24
00810105030303Split Leg Positioner Pair with Pad1-1013-0012020-02-14
00810105030754Adult Arm and Hand Table, No Pad1-1014-0052024-05-13
00810105030761Pediatric Arm and Hand Table No Pad1-1015-0052024-05-13
00810105030778Microsurgical Arm and Hand Table No Pad1-1016-0052024-05-13
00810105030747CMI Spine Frame Arm Covers (12 Pack)4-0009-2042024-04-25
00810105030723Multi Posture Armboard Kit1-1024-0012024-04-03
00810105030587Trigger Lite Armboard2-010-102024-03-22
00810105030594"Trigger Lite Armboard Pad 2"""2-010-10-2WS2024-03-22
00810105030600"Trigger Lite Armboard Pad 3"""2-010-10-3WS2024-03-22
00810105030617"Trigger Lite Armboard Pad 4"""2-010-10-4WS2024-03-22
00810105030624"Trigger Lite Armboard Pad 5"""2-010-10-5WS2024-03-22
00810105030686Skytron Spine Frame3-090-012024-03-22

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