Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037027197

FEI Number

3037027197

Entity Name

SHANGHAI BOJIN MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

A Zone of F2, C Zone of F1, Building 6, No.125, Longpan Road, Jiading District, Shanghai, China, Shanghai 201801, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Bojin Medical Instrument Co., Ltd. (Owner Number: 10091813)

Owner / Operator Contact Address

A Zone of F2, C Zone of F1, Building 6, No.125, Longpan Rd, Jiading District, Shanghai, China, 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

KR-A KR-C KR-B EPM Mueller LTC.; MIS And Mini; Reamer; Reamer ST Saw blades(Non-Sterile) -YBSF Saw blades(Sterile) -NF Saw blades(Non-Sterile) -2SF Saw blades(Non-Sterile) -GF Saw blades(Sterile) -YBSF Saw blades(Non-Sterile) -2SOF Saw blades(Non-Sterile) -GFG Saw blades(Sterile) -YBSFD Saw blades(Non-Sterile) -BJ Saw blades(Sterile) -SOF Saw blades(Non-Sterile) -2BF Saw blades(Sterile) -BF Saw blades(Sterile) -JSO Saw blades(Sterile) -WF Saw blades(Non-Sterile) -3S Saw blades(Sterile) -2HF Saw blades(Sterile) -SM Saw blades(Sterile) -2GF Saw blades(Sterile) -SG Saw blades(Non-Sterile) -WF Saw blades(Sterile) -2XA Saw blades(Sterile) -H Saw blades(Sterile) -SSW Saw blades(Non-Sterile) -YBSFD Saw blades(Sterile) -S Saw blades(Sterile) -2BF Saw blades(Sterile) -SF Saw blades(Non-Sterile) -SOF Saw blades(Sterile) -EF Saw blades(Non-Sterile) -NF Saw blades(Non-Sterile) -XS Saw blades(Sterile) -JSOSW Saw blades(Sterile) -2H Saw blades(Sterile) -SJCZ Saw blades(Non-Sterile) -SSG Saw blades(Sterile) -2S Saw blades(Sterile) -ESG Saw blades(Non-Sterile) -2XA Saw blades(Non-Sterile) -H Saw blades(Non-Sterile) -BJ3501 Saw blades(Non-Sterile) -BF Saw blades(Sterile) -SO Saw blades(Non-Sterile) -SO Saw blades(Sterile) -DJSO Saw blades(Non-Sterile) -DE Saw blades(Non-Sterile) -SF Saw blades(Non-Sterile) -DESO Saw blades(Non-Sterile) -SG Saw blades(Non-Sterile) -M Saw blades(Non-Sterile) -XA Saw blades(Non-Sterile) -2GF Saw blades(Sterile) -BJ Saw blades(Sterile) -WFSW Saw blades(Non-Sterile) -SW Saw blades(Sterile) -2SOF Saw blades(Sterile) -GFG Saw blades(Sterile) -SSG Saw blades(Non-Sterile) -SSW Saw blades(Sterile) -2SF Saw blades(Sterile) -GF Saw blades(Non-Sterile) -S Saw blades(Non-Sterile) -YBF Saw blades(Sterile) -M Saw blades(Non-Sterile) -EF Saw blades(Non-Sterile) -SM Saw blades(Sterile) -DESO Saw blades(Sterile) -3S Saw blades(Sterile) -HF Saw blades(Sterile) -SW Saw blades(Non-Sterile) -BJ3301 Saw blades(Non-Sterile) -2H Saw blades(Sterile) -BJ3301 Saw blades(Sterile) -XA Saw blades(Non-Sterile) -HF Saw blades(Non-Sterile) -2HF Saw blades(Sterile) -BJ3501 Saw blades(Sterile) -XS Saw blades(Non-Sterile) -JSO Saw blades(Non-Sterile) -JSOSW Saw blades(Non-Sterile) -WFSW Saw blades(Non-Sterile) -2S Saw blades(Non-Sterile) -ESG Saw blades(Sterile) -CSW Saw blades(Sterile) -YBF Saw blades(Non-Sterile) -DJSO Saw blades(Non-Sterile) -SJCZ Saw blades(Sterile) -DE Saw blades(Non-Sterile) -CSW BYZ-II 1102 (BJ1102SAO) High speed bone drill BYJZ-I 52 (BJ5200) Multi-functional Handpiece BYJZ-I 54 (BJ5400) Multi-functional Handpiece BYJZ-I 56 (BJ5613B) Pin and wire driver attachment BYJZ-I 84 (BJ8402S) High-speed drill attachment BYJZ-I 66 (BJ6603D) Cannulated drill attachment(Large AO coupling) BJ5513A-A Pin and wire driver attachment BYJZ-I 21 (BJ2107D) Acetabulum reamer attachment BYJZ-I 42 (BJ4202SAO) Small AO drill attachment BYJZ-I 54 (BJ5410) Torque limiter attachment BYZ-II 5503 (BJ5503S) Dual functional cannulated drill BYJZ-I 21 (BJ2107S) Acetabulum reamer attachment BYJZ-I 42 (BJ4203B) Cannulated drill attachment BYJZ-I 54 (BJ5410S) Torque limiter attachment BYJ-II 5506 (BJ5506) Reciprocating saw (Sternum saw) BYJZ-I 21 (BJ2102) High-speed drill attachment BYJZ-I 21 (BJ2112) Oscillating saw attachment BYZ-II 4107 (BJ4107D) Acetabulum reaming drill BYJZ-I 54 (BJ5402SB) High-speed drill attachment BYJZ-I 54 (BJ5413A) Pin and wire driver attachment BYJZ-I 66 (BJ6613B) Pin and wire driver attachment B: 2.1-3.9mm BYJ-II 1101 (BJ1301) Sagittal saw BYJZ-I 21 (BJ2103B) Cannulated drill attachment BYJZ-I 52 (BJ5209) Reciprocating saw attachment BYJZ-I 54 (BJ5403S) Cannulated drill attachment BYJZ-I 66 (BJ6602) High speed bone drill attachment BYJZ-I 21 (BJ2101) Sagittal saw attachment BYJ-II 4106 (BJ4106 ) Reciprocating saw (Sternum saw) BYJZ-I 54 (BJ5402V) Keyless drill attachment BYJZ-I 66 (BJ6609) Reciprocating saw attachment BYZ-II 1103 (BJ1103D) Dual functional cannulated drill BYZ-II 1107 (BJ1307B ) Acetabulum reaming drill BYZ-II 4103 (BJ4103D) Dual functional cannulated drill BYJZ-I 52 (BJ5202SAO) Small AO drill attachment BYJZ-I 54 (BJ5402D) High-speed drill attachment BYJZ-I 66 (BJ6607D) Cannulated drill attachment(Large AO coupling) BYJ-II 1109 (BJ1109) Reciprocating saw BYJZ-I 52 (BJ5207D) Acetabulum reamer attachment BYJ-II 8109 (BJ8109) Reciprocating saw BYJZ-I 66 (BJ6601) Sagittal saw attachment BYZ-II 1103 (BJ1103) Cannulated drill BYZ-II 1103 (BJ1303S) Dual functional cannulated drill BYJZ-I 52 (BJ5201) Sagittal saw attachment BYJZ-I 54 (BJ5402) High-speed drill attachment BYJZ-I 84 (BJ8402SAO) Small AO drill attachment BYJZ-I 66 (BJ6603S) Cannulated drill attachment(Hudson coupling) BYZ-II 1103 (BJ1103B) Dual functional cannulated drill BYZ-II 1107 (BJ1307) Acetabulum reaming drill BYJZ-I 52 (BJ5202) High-speed drill attachment BYJZ-I 54 (BJ5402B) High-speed drill attachment BYJZ-I 84 (BJ8413-I) Pin and wire driver attachment BYJZ-I 66 (BJ6607B) Cannulated drill attachment(Stryker coupling) BYJ-II 1106 (BJ1106) Reciprocating saw (Sternum saw) BYZ-II 4103 (BJ4103B) Dual functional cannulated drill BYZ-II 5102 (BJ5102) High speed bone drill BYJZ-I 52 (BJ5203D) Cannulated drill attachment BYJ-II 8101 (BJ8101) Sagittal saw BYJZ-I 82 (BJ8213A) Pin and wire driver attachment BYZ-II 3402 (BJ3402-IV) Smart driver BJ5513A-B Pin and wire driver attachment BYZ-II 1102 (BJ1102) High speed bone drill BYZ-II 5107 (BJ5107S) Acetabulum reaming drill BYJZ-I 56 (BJ5613) Pin and wire driver attachment BYJZ-I 84 (BJ8413-II) Pin and wire driver attachment BYZ-II 1103 (BJ1103S) Dual functional cannulated drill BYJZ-I 21 (BJ2100) Multi-functional Handpiece BYZ-II 4103 (BJ4103S) Dual functional cannulated drill BYJZ-I 54 (BJ5402S) High-speed drill attachment BYJZ-I 66 (BJ6607S) Cannulated drill attachment(Hudson coupling) BYZ-II 1107 (BJ1107B) Acetabulum reaming drill BYZ-II 5103 (BJ5103B) Dual functional cannulated drill BYJZ-I 52 (BJ5203S) Cannulated drill attachment BYZ-II 8102 (BJ8102) High speed bone drill BYJZ-I 82 (BJ8213B) Pin and wire driver attachment BYZ-II 3407 (BJ3407-IV) Screwing driver BYJZ-I 21 (BJ2109) Reciprocating saw attachment BYJZ-I 42 (BJ4203D) Cannulated drill attachment BYJZ-I 54 (BJ5411) Torque limiter attachment BYZ-II 5507 (BJ5507B) Acetabulum reaming drill BYJZ-I 84 (BJ8400) Multi-functional Handpiece BYJZ-I 21 (BJ2102SAO) Small AO drill attachment BYJZ-I 21 (BJ2113B) Pin and wire driver attachment BYJ-II 4109 (BJ4109) Reciprocating saw BYJZ-I 42 (BJ4207S) Acetabulum reamer attachment BYJZ-I 54 (BJ5403B) Cannulated drill attachment BYJ-II 5501 (BJ5501) Sagittal saw BYJZ-I 82 (BJ8200) Multi-functional Handpiece BYJZ-I 21 (BJ2101S) Sagittal saw attachment BYZ-II 4107 (BJ4107B) Acetabulum reaming drill BYJZ-I 54 (BJ5402SAO) Small AO drill attachment BYJZ-I 54 (BJ5413) Pin and wire driver attachment BYJZ-I 66 (BJ6613A) Pin and wire driver attachment A: 0.6-2mm BYZ-II 4103 (BJ4103) Cannulated drill BYJ-II 5101 (BJ5101S) Sagittal saw BYJZ-I 52 (BJ5203B) Cannulated drill attachment BYZ-II 5503 (BJ5503D) Dual functional cannulated drill BYJZ-I 58 (BJ5813B) Pin and wire driver attachment BYJZ-I 82 (BJ8209) Reciprocating saw attachment BYJ-II 3401 (BJ3401-IV) Smart sagittal saw BYZ-II 4102 (BJ4102) High speed bone drill BYJZ-I 42 (BJ4201) Sagittal saw attachment BYJZ-I 42 (BJ4213A) Pin and wire driver attachment BYZ-II 4102 (BJ4102A) High speed bone drill BYJ-II 5501 (BJ5501-II) Sagittal saw BYJZ-I 42 (BJ4201S) Sagittal saw attachment BYJZ-I 42 (BJ4213B) Pin and wire driver attachment BYJZ-I 82 (BJ8202) High-speed drill attachment BYJ-II 5501 (BJ5501S) Sagittal saw BYJZ-I 58 (BJ5800) Multi-functional Handpiece BYJZ-I 82 (BJ8202SAO) Small AO drill attachment BYJ-II 1101 (BJ1101S) Sagittal saw BYJZ-I 42 (BJ4207D) Acetabulum reamer attachment BYZ-II 5107 (BJ5107D) Acetabulum reaming drill BYJZ-I 56 (BJ5600) Multi-functional Handpiece BYJZ-I 84 (BJ8409) Reciprocating saw attachment BYZ-II 1102 (BJ1302) High-speed bone drill BYJZ-I 21 (BJ2103D) Cannulated drill attachment BYJZ-I 52 (BJ5213A) Pin and wire driver attachment BYJZ-I 54 (BJ5407) Acetabulum reamer attachment BYJZ-I 66 (BJ6602SAO) Small AO drill attachment SGJ-IV-BY1201S (BJ1201S-IV) Plaster cutting saw BYZ-II 1107 (BJ1107S) Acetabulum reaming drill BYJZ-I 52 (BJ5207B) Acetabulum reamer attachment BYZ-II 8103 (BJ8103) Cannulated drill BYJZ-I 66 (BJ6600) Multi functional handpiece BYZ-II 1107 (BJ1107D) Acetabulum reaming drill BYZ-II 5103 (BJ5103D) Dual functional cannulated drill BYJZ-I 52 (BJ5206) Reciprocating saw attachment (Sternum saw) BYZ-II 8102 (BJ8102SAO) High speed bone drill BYJ-II 3409 (BJ3409) Smart reciprocating saw BYZ-II 1102 (BJ1102A) High speed bone drill BYJ-II 5109 (BJ5109) Reciprocating saw BYJZ-I 56 (BJ5613A) Pin and wire driver attachment BYJZ-I 84 (BJ8401-II) Sagittal saw attachment BYJZ-I 66 (BJ6603B) Cannulated drill attachment(Stryker coupling) BYZ-II 4102 (BJ4102SAO) High speed bone drill BYJ-II 5101 (BJ5101H) Sagittal saw BYZ-II 5503 (BJ5503B) Dual functional cannulated drill BYJZ-I 58 (BJ5813A) Pin and wire driver attachment BYJZ-I 82 (BJ8207) Low speed drill attachment BYJZ-I 84 (BJ8418) Oscillating saw attachment BYZ-II 1107 (BJ1307S) Acetabulum reaming drill BYJZ-I 52 (BJ5207S) Acetabulum reamer attachment BYJZ-I 54 (BJ5403D) Cannulated drill attachment BYZ-II 8113 (BJ8113A) Pin and wire driver BYJZ-I 66 (BJ6601H) Sagittal saw attachment BYJZ-I 21 (BJ2102B) High-speed drill attachment BYJZ-I 21 (BJ2113A) Pin and wire driver attachment BYZ-II 4107 (BJ4107S) Acetabulum reaming drill BYJZ-I 54 (BJ5403) Cannulated drill attachment BYJZ-I 54 (BJ5413B) Pin and wire driver attachment BYZ-II 8113 (BJ8113B) Pin and wire driver BYZ-II 1103 (BJ1303B ) Dual functional cannulated drill BYJZ-I 21 (BJ2106) Reciprocating saw attachment (Sternum saw) BYJZ-I 42 (BJ4202) High-speed drill attachment BYJZ-I 52 (BJ5213B) Pin and wire driver attachment BYJZ-I 54 (BJ5407B) Acetabulum reamer attachment BYJZ-I 21 (BJ2110) Torque limiter attachment BYJZ-I 42 (BJ4203S) Cannulated drill attachment BYZ-II 5103 (BJ5103S) Dual functional cannulated drill BYJZ-I 54 (BJ5411S) Torque limiter attachment BYZ-II 5507 (BJ5507D) Acetabulum reaming drill BYJZ-I 84 (BJ8401) Sagittal saw attachment BYZ-II 1103 (BJ1303D) Dual functional cannulated drill BYJZ-I 21 (BJ2107) Acetabulum reamer attachment BYJZ-I 42 (BJ4202A) High-speed drill attachment BYJZ-I 54 (BJ5407D) Acetabulum reamer attachment SGJ-III-BY1201 (BJ1201-III) Plaster cutting saw with vacuum cleaner BYJZ-I 21 (BJ2111) Torque limiter attachment BYJZ-I 42 (BJ4206) Reciprocating saw attachment (Sternum saw) BYJ-II 5106 (BJ5106) Reciprocating saw (Sternum saw) BYZ-II 5507 (BJ5507S) Acetabulum reaming drill BYJZ-I 84 (BJ8402) High-speed drill attachment BYJ-II 1101 (BJ1101) Sagittal saw BYJZ-I 42 (BJ4207B) Acetabulum reamer attachment BYZ-II 5107 (BJ5107B) Acetabulum reaming drill BYJ-II 5509 (BJ5509) Reciprocating saw BYJZ-I 84 (BJ8403) Cannulated drill attachment BYJZ-I 21 (BJ2107B) Acetabulum reamer attachment BYJZ-I 42 (BJ4202B) High-speed drill attachment BYJZ-I 54 (BJ5407S) Acetabulum reamer attachment BYZ-II 4102 (BJ4102B) High speed bone drill BYJ-II 5101 (BJ5101) Sagittal saw BYZ-II 5502 (BJ5502) High speed bone drill BYJZ-I 58 (BJ5813) Pin and wire driver attachment BYJZ-I 82 (BJ8203) Cannulated drill attachment BYJZ-I 21 (BJ2103) Cannulated drill attachment BYJ-II 4101 (BJ4101) Sagittal saw BYJZ-I 42 (BJ4200) Multi-functional Handpiece BYJZ-I 42 (BJ4209) Reciprocating saw attachment BYJ-II 5501 (BJ5501H) Sagittal saw BYJZ-I 82 (BJ8201) Sagittal saw attachment

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2025-06-25
HTO	Reamer	Orthopedic	Class 1	888.4540	2025-02-25
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2026-03-31
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-02-25

Official Correspondent

QINGYUAN WANG

US Agent Details

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

Related Public Records

Same Entity

Shanghai Bojin Medical Instrument 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
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
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.

Similar Registrations

Registration Number	Establishment Name	Location
3032611331	CALEB CO., LTD.	Won-Ju-Si Gangwon, KR
3012964172	ELITE MEDTEK(JIANGSU) CO., LTD	Changzhou City Jiangsu, CN
3009217531	Eurofins STERIPAC GMBH	Calw-Altburg Baden-Wurttemberg, DE
1718850	LivaNova USA, INC.	ARVADA, CO, US
3045076544	BEIJING YUEWEI MEDICAL TECHNOLOGY CO., LTD	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037027197. Last updated year: 2026. Please use registration number 3037027197 when referencing this establishment in official correspondence.