FDA.reportPublic FDA data

RAZOR Calcar Planer Handle

Primary DI
00850022768187
Brand
RAZOR Calcar Planer Handle
Company
Razor Medical Instruments, Inc.
Model
1103-0000
Catalog number
1103-0000
Device description
Calcar Planer Handle
Published
2023-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00850022768187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022768187008500227681878500227681870850022768187

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

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
00196449010196Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449010288Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035243Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035250Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035267Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00810094692698Modular Frog EyesTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692704Distal Femoral Cut Block ConnectorTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692933Magnet Spacer, 5mmTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
04052536123728mamboUlrich GmbH & Co. KGLXH2026-06-09
08809945870578BENCOXCorentec Co., LtdLXH2026-06-09
04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162079neon3Ulrich GmbH & Co. KGLXH2026-06-08
00198506091445ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-05
00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03