FDA.reportPublic FDA data

DISTRACTION COMPRESSION CASE

Primary DI
00810019931475
Brand
DISTRACTION COMPRESSION CASE
Company
Bradshaw Medical, Inc.
Model
MRS-103
Device description
A distraction-compression case is a kit, or a set of instruments designed to perform distraction and compression on a bony structure. The instruments within the case are used to:Distract: To pull apart or lengthen two adjacent bony segments. This is often done to restore anatomical alignment, decompress a nerve, or create a space for a bone graft or implant.Compress: To push together two bony segments. This is typically done to stabilize a fracture, achieve a solid fusion, or close a gap between bones.These kits are essential for orthopedic and spinal surgeons to manipulate bones and achieve proper fixation
Published
2025-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810019931475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810019931475008100199314758100199314750810019931475

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
621830582
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810019931574Concentrical blade - length 50 mmMRS-108-0502025-08-12
00810019931598Concentrical blade - length 70 mmMRS-108-0702025-08-12
00810019931604Concentrical blade - length 80 mmMRS-108-0802025-08-12
00810019931628Concentrical blade - length 90 mmMRS-108-0902025-08-12
00810019931635Concentrical blade - length 100 mmMRS-108-1002025-08-12
00810019931642Concentrical blade - length 110 mmMRS-108-1102025-08-12
00810019931659Concentrical blade - length 120 mmMRS-108-1202025-08-12
00810019931666Concentrical blade - length 130 mmMRS-108-1302025-08-12
00810019931673Plate blade with teeth - length 50 mmMRS-109-0502025-08-12
00810019931680Plate blade with teeth - length 60 mmMRS-109-0602025-08-12
00810019931697Plate blade with teeth - length 70 mmMRS-109-0702025-08-12
00810019931710Plate blade with teeth - length 90 mmMRS-109-0902025-08-12
00810019931727Plate blade with teeth - length 100 mmMRS-109-1002025-08-12
00810019931734Plate blade with teeth - length 110 mmMRS-109-1102025-08-12
00810019931741Plate blade with teeth - length 120 mmMRS-109-1202025-08-12
00810019931758Plate blade with teeth - length 130 mmMRS-109-1302025-08-12
00810019931765Plate blade without teeth - length 50 mmMRS-110-0502025-08-12
00810019931703Plate blade with teeth - length 80 mmMRS-109-0802025-08-11
00810019931772Plate blade without teeth - length 60 mmMRS-110-0602025-08-11
00810019931789Plate blade without teeth - length 70 mmMRS-110-0702025-08-11

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