FDA.reportPublic FDA data

RAZOR Calcar Planer

Primary DI
00850022768170
Brand
RAZOR Calcar Planer
Company
Razor Medical Instruments, Inc.
Model
1102-0038-P
Catalog number
1102-0038-P
Device description
38mm Calcar Planer
Published
2023-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022768170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022768170008500227681708500227681700850022768170

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, single-useAn orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy available in varying sizes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter38Millimeter

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
8003580434qa@razormi.com

Regulatory Flags#

DUNS number
117571863
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022768200RAZOR Single-Use Acetabular Reamer1001-00461001-00462023-11-08
00850022768217RAZOR Single-Use Acetabular Reamer1001-00471001-00472023-11-08
00850022768224RAZOR Single-Use Acetabular Reamer1001-00481001-00482023-11-08
00850022768231RAZOR Single-Use Acetabular Reamer1001-00491001-00492023-11-08
00850022768248RAZOR Single-Use Acetabular Reamer1001-00501001-00502023-11-08
00850022768255RAZOR Single-Use Acetabular Reamer1001-00511001-00512023-11-08
00850022768262RAZOR Single-Use Acetabular Reamer1001-00521001-00522023-11-08
00850022768279RAZOR Single-Use Acetabular Reamer1001-00531001-00532023-11-08
00850022768286RAZOR Single-Use Acetabular Reamer1001-00541001-00542023-11-08
00850022768293RAZOR Single-Use Acetabular Reamer1001-00551001-00552023-11-08
00850022768309RAZOR Single-Use Acetabular Reamer1001-00561001-00562023-11-08
00850022768316RAZOR Single-Use Acetabular Reamer1001-00571001-00572023-11-08
00850022768323RAZOR Single-Use Acetabular Reamer1001-00581001-00582023-11-08
00850022768330RAZOR Single-Use Acetabular Reamer1001-00591001-00592023-11-08
00850022768347RAZOR Single-Use Acetabular Reamer1001-00601001-00602023-11-08
00850022768354RAZOR Single-Use Acetabular Reamer1001-00611001-00612023-11-08
00850022768361RAZOR Single-Use Acetabular Reamer1001-00621001-00622023-11-08
00850022768378RAZOR Single-Use Acetabular Reamer1001-00631001-00632023-11-08
00850022768385RAZOR Single-Use Acetabular Reamer1001-00641001-00642023-11-08
00850022768392RAZOR Single-Use Acetabular Reamer1001-00651001-00652023-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094692797Tibial Reamer, Square Tip, Klassic ONE 25/50mmTOTAL JOINT ORTHOPEDICS, INC.HTO2026-06-09
00810030810575InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810582InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810599InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810605InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810612InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810629InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810636InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810643InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810650InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810667InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810674InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810681InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810698InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810704InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810414InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810421InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810438InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810445InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810452InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810469InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810476InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810483InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810490InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810506InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810513InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810520InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810537InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810544InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810551InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31