FDA.reportPublic FDA data

Orthopedic Fracture Attachment Kit, Berchtold

Primary DI
00810105030006
Brand
Orthopedic Fracture Attachment Kit, Berchtold
Company
COMPOSITE MANUFACTURING, INC.
Model
3-1000-001
Catalog number
OZ 7531775
Device description
Orthopedic fracture attachment system used to pull traction and articulate the legs of patient for various procedures.
Published
2021-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00810105030006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810105030006008101050300068101050300060810105030006

GMDN Terms#

Term, Definition table
TermDefinition
Operating table orthopaedic extensionAn orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table or table top to provide additional support to a patient's body segment or part during orthopaedic surgical procedures (e.g., lower trunk for traction of the legs, upper body during shoulder surgery). It typically consists of height, length and angle adjustable supports or telescopic bars/plates.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9493617580bmccarron@carbonfiber.com

Regulatory Flags#

DUNS number
947090650
Device count
1
Premarket exempt
true
Serial number
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
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
00810105030730CMI Spine Frame Head Foam Supports (12 Pack)4-0009-2032024-04-25
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