Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008787426

FEI Number

3008787426

Entity Name

SHANGHAI BOJIN ELECTRIC INSTRUMENT & DEVICE CO.,LTD.

City/State/Country

Shanghai, CN

Establishment Address

B322&323,No.1128, Huichengnan Road, Jiading District, Shanghai 201800, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Bojin Electric Instrument & Device Co.,Ltd. (Owner Number: 10034955)

Owner / Operator Contact Address

Room 211-215, No.125,Longpan Road,Jiading District, Shanghai, CN-SH 201801, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Reamer EPM Mueller LTC. Reamer ST MIS And Mini BJXZ-4-30-65 MILLING BUR BJ1401 SAGITTAL SAW BJ2107B ACETABULUM REAMING DRILL ATTACHMENT BJ4003 LID BJ4301 SAGITTAL SAW BJ4403D (Cannulated Drill Attachment) BJ5407D (Acetabulum Reaming Drill Attachment) BJ8213A K-WIRE DRILLATTACHMENT BJ8413A K-Wire Driver Attachment BJXXZ-2.7-13.5-65 MILLING BUR BJ1109 RECIPROCATING SAW BJ1403B DUAFUNCTION CANULATE DRILL BJ43001 BATTERY BJ4303B DUAL FUNCTION CANULATE DRILL BJ8005 KEY BJ8400 Muti-Functional Handpiece BJXXZ-3-8-65 MILLING BUR BJXXZ-2.2/3-21-73.5 MILLING BUR BJ1201 MEDICAL ELECTRIC PLASTER CUTTING SAW BJ2100 MULT-FUNCTION HANDPIECE BJ35007 Power Line BJ4400 (Multi-Function Handpiece) BJ5503D Cannulated Drill BJ8103 CANULATE DRILL BJ84003 Battery Case BJ-S5002-4 Multi-Charger BJ1103B1(7-14)MEDULLARY REAMER BJ2103B CANULATE DRILL ATTACHMENT BJ34001 BATTERY BJ3513 K-Wire Drill Attachment BJ4107 ACETABULUM REAMING DRILL BJ5103B (Cannulated Drill) BJ5602 Bone Drill Attachment BJ6003 LID BJ8402SAO AO Drill Attachment SU11001 Battery BJ1103S1(7-14)MEDULLARY REAMER(HUDSON) BJ3402 SMART DRILL-FAST(NEW) BJ4109 RECIPROCATING SAW BJ5107D Acetabulum Reaming Drill BJ53002 Charger BJ6007 CONNECTION WRE BJXZ-2-12-65 MILLING BUR Pneumatic Powered - 300MM GUIDE WIRES (NON-IMPLANTABLE BJ2102 BONE DRILL ATTACHMENT BJ32011(1-6) CUTTING DRILL BIT BJ3502 Straight Attachment BJ4402 CANULATE BONE DRILL ATTACHMENT BJ4413B (2-3) K-Wire Drill Attachment BJ5507D Acetabulum Reaming Drill BJ8401 Sagittal Saw Attachment S2002-2 Charger BJXXZ-2-20-70 MILLING BUR Surgical Instrument BJ2101S STRYKER SAGITTAL SAW ATTACHMENT BJ35012 Foot Control BJ4402 (Bone Drill Attachment) BJ4413A (0.8-2)K-Wire Drill Attachment BJ5507B (Acetabulum Reaming Drill-High Torque) BJ84005 Multi Charger BJXXZ-1.2/2.3-16-65 MILLING BUR BJ1101 SAGITTAL SAW BJ2111 TORQUE LIMITER ATTACHMENT BJ41021SAO(2-4.5) AO TWIST DRILL BIT BJ4407D CANULATE ACETABULUM DRILL ATTACHMENT BJ5201 Sagittal Saw Attachment BJ5503B (Cannulated Drill) BJ5802 Dual Drill/Ream Attachment Diamond Ground BJ11021(2-4.5)TWIST DRILL BIT BJ2113A K-WIRE DRILL ATTACHMENT BJ4102SAO AO DRILL BJ4203B CANULATE DRILL ATTACHMENT FOR TRAUMA PROCEDURES BJ4407S STRYKER CANULATE ACETABULUM DRILL ATTACHMENT BJ5202SAO (AO Drill Attachment) BJ5802D Dual Drill/Ream Attachment Bojin Coupling BJ1107B1(36-64) ACETABULUM REAMER BJ1201S MEDICAL ELECTRIC PLASTER CUTTING SAW BJ4202SAO AO DRILL ATTACHMENT FOR TRAUMA PROCEDURES BJ43003 BATTERY STERILIZATION CONTAINER BJ5306 Sternum Saw BJ6103B DUAL FUNCTION CANULATE DRILL BJ8200 MULTI-FUNCTION HANDPIECE BJ3603-II-70 BJ1002-4 MULTI-FUNCTION CHARGER BJ1103D1(7-14)MEDULLARY REAMER BJ3401 SMART SAW (NEW) BJ4108 OVERHAUL SAW BJ5107B (Acetabulum Reaming Drill) BJ53001 Battery (9.6V 1800mAh) BJ5607D Acetabulum Reaming Drill Attachment BJ6006 POWER CONSOLE SU11004 Aseptic Transfer Kit BJ37012 BJ11061 PROTECTION OF SUPPORT BJ1201-III ELECTRIC CAST CUTTER WITH VACUUM CLEANER BJ3500 Powertool BJ4201 SAGITTAL SAW ATTACHMENT FOR JOINTPROCEDURES BJ43002-4B Mult-Function Charger BJ3609 BJ53003 Battery Case BJ6009 LID BJ8113A K-WIRE DRILL BJ-S5001 Battery BJ2103 CANULATE DRILLATTACHMENT BJ3207 4:1 Reducer BJ3507SAO Small AO Coupling Drill Attachment(16: 1) BJ4106 STERNUM SAW BJ4402SAO (AO Drill Atachment) BJ5102 Bone Drill BJ5600 Multi Function Handpiece BJ8402S Hudson Bone Drill Attachment S4112 Battery BJ6603D BJXXZ-2-9-65 MILLING BUR BJ12002 CHARGER BJ2003 LID BJ35006 Power Adaptor BJ43002 CHARGER BJ4309 RECIPROCATNGSAW FOR SURGERY OPERATION BJ8102 BONE DRILL BJ84002 Charger BJ3600 BJ6602SAO BJ6600 BJ6602B BJXZ-2.7-13.5-65 MILLING BUR BJ1302 POPULARIZED BONE DRILL BJ43004 ASEPITIC TRANSFER KIT BJ5400 + BJ5402 (Bone Drill) BJ5402SAO (AO Drill Attachment) BJ8202 BONE DRILLATTACHMENT BJ6602 BJXZ-2-13-65 MILLING BUR BJ1107B1L REAMER SHAFT BJ1202 ECONOMICAL BONE DRILL BJ43003: Battery Sterilization Container BJ5400 Multi-Function Handpiece) BJ5402 (Bone Drill Attachment) BJ6107B DUAL-FUNCTION ACETABULUM REAMING DRILL BJ8201 SAGITTAL SAW ATTACHMENT BJXXZ-1.6/2.3-20-74 MILLING BUR BJ1004 ASPETIC TRANSFER KIT BJ2109 RECIPROCATING SAW ATTACHMENT BJ4101 SAGITTAL SAW BJ4407B CANULATE ACETABULUM DRILL ATTACHMENT BJ5501 (Sagittal Saw) BJ5613 K-Wire Driver Attachment BJ8418 Oscillating Saw Attachment BJ36006 BJXZ-3.1/4.1-12.5-65 MILLING BUR BJ1003 LID BJ1402 BONE DRILL BJ2107D CANULATE DRILL ATTACHMENT BJ4004 ASEPTIC TRANSFER KIT BJ4407B (Acetabulum Reaming Drill Atachment) BJ5413 (K-WireDriver Attachment) BJ5607S Acetabulum Reaming Drill Attachment BJ8213B K-WIRE DRILL ATTACHMENT BJ8413B K-Wire Driver Attachment BJ6607S BJ6613A BJXXZ-2-20-100 MILLING BUR BJ1005 KEY BJ2110 TORQUE LIMITER ATTACHMENT BJ4102 BONE DRILL BJ4407D (Acetabulum Reaming Drill Attachment) BJ5200 (Multi Function Handpiece) BJ5501-II Sagittal Saw BJ5800 Multi-Functional Handpiece BLADE BJ37006 BJXZ-2-20-0 MILLING BUR BJ14001 BATTERY BJ43004:Aseptic Transfer Kit BJ4402SAO CANULATE AO BONE DRILL ATTACHMENT BJ5400 + BJ5413 (K-Wire Driver) BJ5403B Cannulated Drill Attachment) BJ8202SAO AO DRILL ATTACHMENT BJ6602S 900MM GUIDE WIRES (NON-IMPLANTABLE) BJ2102SAO AO BONE DRILL ATTACHMENT BJ32012(1-6) DIAMOND DRILL BIT BJ3502SAO Small AO Coupling Drill Attachment(4:1) BJ4402S STRYKER CANULATE BONE DRILL BJ5101 ( Sagittal Saw) BJ5509 Reciprocating Saw BJ8402 Bone Drill Atachment S2011 Aseptic Transfer Kit BJ3602-II-45 BJ3601 BJXXZ-4-8-65 MILLING BUR Motor BJ2101 SAGITTAL SAW ATTACHMENT BJ3501 Sagittal Saw Attachment BJ4400 MULTI-FUNCTION HANDPIECE BJ5506 Sternum Saw BJ84004 Aseptic Transfer Kit BJ6603S BJ3602-II-70 BJ6607B BJ1102A DUAL FUNCTION BONE DRILL BJ1107B1T DETACHABLE AND LENGTHENED BJ2113B K-WIRE DRILI ATTACHMENT BJ4103 CANULATE DRILL BJ4203D CANULATE DRILL ATTACHMENT FOR TRAUMA PROCEDURES BJ5203B/BJ5203S (Cannulated Drill Attachment) BJ5802S Dual Drill/Ream Attachment BJ6200 MULTI FUNCTION HANDPIECE Zimmer Coupling BJXZ-2-22.5-65 MILLING BUR BJ14002 CHARGER BJ2103D CANULATE DRILL ATTACHMENT BJ43005 KEY BJ4403B (Cannulated Drill Attachment) BJXXZ-2-8-65 MILLING BUR BJ5403D (Cannulated Drill Attachment) BJ12001 BATTERY BJ1407B ACETABULUM REAMING DRILL BJ43001 Battery (12V 1300mAh) BJ8203 CANULATE DRILLATTACHMENT BJ4307B ACETABULUM REAMING DRILL BJ8403 Cannulated Drill Attachment BJ8101 SAGITTAL SAW BJ84001 Battery BJ9800 BJ6607D BJ1107B ACETABULUM REAMING DRILL BJ12011 FLAT WRENCH BJXZ-2.5-30-65 MILLING BUR BJ14004 ASEPTIC TRANSFER KIT BJ4202 BONE DRILL ATTACHMENT FOR TRAUMA PROCEDURES BJ43002: Charger BJ2106 STERNUM SAW ATTACHMENT BJ5301 (Sagittal Saw) BJ43005: Key BJ4403B CANULATE DRILL ATTACHMENT BJ6101 SAGITTAL SAW BJ5407B (Acetabulum Reaming Drill Attachment) BJ8209 RECIPROCATING SAW ATTACHMENT BJ8409 Reciprocating Saw Attachment BJ8113B K-WIRE DRILL BJXXZ-2-13-65 MILLING BUR BJ11081 OVERHAUL SAW BLADE BJ4300 MULTI-FUNCTION HANDPIECE BJ4302 BONE DRILL FOR JOINT PROCEDURES BJ5209 Reciprocating Saw Attachment BJ6602D BJ8002 CHARGER BJ3618 BJ1106 STERNUM SAW BJ3407 SMART DRILL-SLOW(NEW) BJXXZ-1.2/2.3-12.5-65 MILLING BUR BJ4200 MULTLFUNCTION HANDPIECE BJ1103B DUAL FUNCTION CANULATE DRILL BJ1107D1T DETACHABLE AND LENGTHENED BJ4213A K-WIRE DRILL ATTACHMENT BJ5207B/BJ5207S (Acetabulum Reaming Drill Attachment) BJ6001 BATTERY BJ6207B ACETABULUM REAMING DRILL ATTACHMENT BJ43002-4B MULTI-FUNCTION CHARGER BJ3602-II-110 BJ5109 (Reciprocating Saw) BJ53002-4 Multi-Charger BJ6008 BATTERY BJ3603-II-45 BJ36012 BJ6601 BJ1102A6 JACOB CHUCK BJ1107D1(36-64)ACETABULUM REAMER BJ4103B DUAL FUNCTION CANULATE DRILL BJ4207B ACETABULUM REAMING DRILL BJ5203D (Cannulated Drill Attachment) BJ5802SAO Small AO Quick Coupling BJ6201 SAGITTAL SAW ATTACHMENT BJ1103 CANULATE DRILL BJ1107D1L REAMER SHAFT BJ4103D DUAL FUNCTION CANULATE DRILL BJ4207D ACETABULUM REAMING DRILL ATTACHMENT FOR JOINT PROCEDURES BJ5206 Sternum Saw Attachment BJ5813 K-Wire Driver BJ6203 CANULATE DRILLATTACHMENT BJ3603-II-110 BJ6613B BJ1002 CHARGER BJ1103D DUAL FUNCTION CANULATE DRILL BJ34004 ASEPTIC TRANSFER KIT BJ4001 BATTERY BJ4107D DUAL-FUNCTION ACETABULUM REAMING DRILL BJ5106 Sternum Saw BJ5213-II K-Wire Driver Attachment BJ5607B Acetabulum Reaming Drill Attachment BJ6004-2 ASEPTIC TRANSFERKIT SU11003 Battery Case BJ1102 BONE DRILL BJ2112 TPLO ATTACHMENT BJ4102A DUAL FUNCTIONBONE DRILL BJ4407S (Acetabulum Reaming Drill Attachment) BJ5202 (Bone Drill Attachment) BJ5802B Dual Drill/Ream Attachment Standard Offset BJXXZ-2.7/3.1-12.5-65 MILLING BUR BJ1108 OVERHAUL SAW BJ4213B K-WIRE DRILL ATTACHMENT BJ5207D Acetabulum Reaming Drill Attachment) BJ8001 BATTERY BJ1001 BATTERY BJ1103B8 JACOBCHUCK BJ34002 CHARGER BJ3517 Angle Transmission Adaptor BJ4107B DUAL-FUNCTION ACETABULUM REAMING DRILL BJ5103D Cannulated Drill BJ5602SAO AO Drill Attachment BJ6004-1 ASEPTIC TRANSFER KIT SU11002 Charger BJ6603B BJ6609 BJ6603 SAW BLADE(Sterile) SAW BLADE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTO	Reamer	Orthopedic	Class 1	888.4540	2011-01-20
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2011-01-20
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2026-04-10

Official Correspondent

Xijiong Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shanghai Bojin Electric Instrument & Device Co.,Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K953432	Midas Rex Pneumatic Tools, Inc.	ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS	1995-09-14
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008787426. Last updated year: 2026. Please use registration number 3008787426 when referencing this establishment in official correspondence.