FDA.reportPublic FDA data

Bojin

Primary DI
06975069299754
Brand
Bojin
Company
Shanghai Bojin Medical Instrument Co., Ltd.
Model
BJJDR-12.0-22-470-B
Published
2026-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975069299754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975069299754069750692997546975069299754

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
420078547
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942297807716BojinBJJDR-13.0-22-470-D 2026-04-09
06942297807853BojinBJJDR-9.0-22-470-S2026-04-09
06942297807860BojinBJJDR-10.5-22-470-S 2026-04-09
06942297807877BojinBJJDR-11.0-22-470-S2026-04-09
06942297807884BojinBJJDR-11.5-22-470-S2026-04-09
06942297807891BojinBJJDR-12.0-22-470-S2026-04-09
06942297807907BojinBJJDR-12.5-22-470-S2026-04-09
06942297807914BojinBJJDR-13.0-22-470-S 2026-04-09
06973011520017BojinBJJDR-13.0-22-470-B2026-04-09
06975069296333BojinBJJDR-10.0-22-470-B2026-04-09
06975069296357BojinBJJDR-10.0-22-470-S 2026-04-09
06975069296586BojinBJJDR-9.5-22-470-D2026-04-09
06975069296593BojinBJJDR-9.5-22-470-S2026-04-09
06975069299709BojinBJJDR-9.0-22-470-B2026-04-09
06975069299716BojinBJJDR-9.5-22-470-B2026-04-09
06975069299723BojinBJJDR-10.5-22-470-B 2026-04-09
06975069299730BojinBJJDR-11.0-22-470-B2026-04-09
06975069299747BojinBJJDR-11.5-22-470-B 2026-04-09
06975069299761BojinBJJDR-12.5-22-470-B2026-04-09
06975069299945BojinBJJDR-9.0-22-470-D2026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400552MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400576MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400644MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402075MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402082MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402204MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400293MillenniumAvalign Technologies, Inc.HTW2026-07-17
18257200076536CETRAOrthofix US LLCHTW2026-07-17
18257200076574CETRAOrthofix US LLCHTW2026-07-17
18257200131211Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200131228Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200131273Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200163823PILLAR SA TiOrthofix US LLCHTW2026-07-17
18257200163854PILLAR SA TiOrthofix US LLCHTW2026-07-17
07630008439866APTUSMedartis AGHTW2026-07-16
07630037811374APTUSMedartis AGHTW2026-07-16
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
09353903030317OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
09353903030324OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
00190776395438MillenniumAvalign Technologies, Inc.HTW2026-07-13
00190446932406Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948216Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948483Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-06-24
00889795154507Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154514Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154521Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154606Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
08800089483433Drill bitJeil Medical CorporationHTW2026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTW2026-06-10