MANMAN MANUFACTURING COMPANY PRIVATE LIMITED

FDA Device Registration & Listing · Pune Maharashtra, IN · Registration 3013893019

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013893019
FEI Number
3013893019
Entity Name
MANMAN MANUFACTURING COMPANY PRIVATE LIMITED
City/State/Country
Pune Maharashtra, IN
Establishment Address
1157, Sadashiv Peth, Pune Maharashtra 411030, IN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Manman Manufacturing Company Private Limited (Owner Number: 10088853)
Owner / Operator Contact Address
1157, Sadashiv Peth, Pune, IN-MH 411030, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Manman Element Funnel(EO2221100) Manman NXG Pin Colet Attachment 0.8 to 1.9 mm(E21161000) Manman NXG Pin Colet Attachment 2 to 4 mm(E21161400) Manman Swift V3 Funnel(V32111400) Manman NXG Pin Colet Attachment 0.8 to 1.9 mm(DVNXMD2350600 ) Manman Combi Coupler(DVNXMD2350900) Manman NXG Drill Chuck Adapter(DVNXMD2350500) Manman NXG Pin Colet Attachment 2 to 4 mm(DVNXMD2350700) Manman BCDR Electrical Wire Driver Handpiece Manman Legacy Angular Burr Attachment 75mm Manman Swift V3 Reaming Attachment AO Quick Coupling 400 rpm Manman Legacy Straight Burr Attachment 5.5 mm X75mm Manman BCDR Electrical Driving Unit 90W, Manman Swift V3 Drill Attachment 1400 rpm Manman Legacy Twisted Drill Bit 1.5 mm X 10 mm X 75mm Manman BCDR system Electrical Mains Manman Legacy Angular Burr Attachment 120mm Manman BCDR Electrical Handpiece with AO Coupling 800 rpm Manman BCDR Electrical Drill Handpiece with Jacob Chuck and key 1200 rpm Manman Synthes End Adaptor Manman Element Power Module Manman Swift V3 Drilling Attachment with Jacob Keyless Chuck Manman BCDR Electrical Reaming Handpiece AO Coupling 400 rpm Manman BCDR Electrical Driving Unit 200W. Manman Chuck Key 6mm Manman Swift V3 Reaming Attachment Hudson Quick Coupling 400 rpm Manman Legacy Straight Burr Attachment 5.5 mm X120 mm Manman Trinkle End Adaptor Manman Hudson End Adaptor Manman Bone cutting Drilling and Reaming System Ortho & Cardiac Battery Manman Zimmer Quick Coupling Adaptor Jacob Chuck Key 4 mm Jacob Chuck Key 6 mm Manman Legacy Angular Burr Attachment 95mm Manman Swift V3 Drilling Attachment Hudson Quick Coupling Manman Swift V3 Reaming Attachment Hudson Quick Coupling 1000 rpm Manman Legacy Straight Burr Attachment 5.5 mm X 95mm Manman Swift V3 Wire Driving Attachment Manman Swift V3 Pin Driving Attachment Manman Swift V3 Drill Attachment Manman Drill Chuck Adaptor with key 0 to 6 mm Manman Swift V3 Reaming Attachment 1000 rpm Manman Legacy Straight Burr Attachment 5.5 mm X45 mm Manman BCDR Electrical Reverse Forward Drill Handpiece with Jacob Chuck and Key 800rpm Manman Swift V3 Drilling Attachment Synthes Quick Coupling 1000 rpm Manman Swift V3 Reaming Attachment Zimmer Quick Coupling 1000 rpm Legacy system with accessories or attachments Manman Swift V3 Drilling Attachment Trinkle Quick Coupling Plaster Cutters with accessories or attachments Manman Swift V3 Drilling Attachment Zimmer Quick Coupling Manman BCDR Electrical Driving Unit 200W 110 V, Manman Swift V3 Battery Operated Asetabular Reaming Attachment 600 rpm Manman BCDR Electrical Driving Unit 90W 110 V, Manman Legacy Shaver Spherical Burr 3 x 147 SN(MLSCSB3147SN) Manman Legacy Shaver Teardrop Cutter 4 x 355(MLSCSB4355M) Manman Legacy Shaver Double Serrated Burr 5 x 192 CL(MLSCDS5192CL) Manman Legacy Shaver Internal Tooth Burr 3 x 147(MLSCIT3147M) Manman Legacy Shaver Teardrop Cutter 3 x 187 S(MLSCSB3187S) Manman Legacy Shaver Double Serrated Burr 5 x 192 SN(MLSCDS5192SN) Manman Legacy Shaver Toothless Cutter 5 x 192 (MLSCTLC5192M) Manman Legacy Shaver Spherical Burr 4 x 355(MLSCSB4355M) Manman Legacy Shaver Teardrop Cutter 4 x 192 CL(MLSCSB4192CL) Manman Legacy Diamond Burr Tool 6 mm X 45mm(QR 213 61 10 ) Manman Legacy Shaver Double Serrated Burr 3 x 187 A(MLSCDS3187A) Manman Legacy Shaver Spherical Burr 4 x 147(MLSCSB4147M) Manman Legacy Shaver Spherical Burr 5 x 192 CL(MLSCSB5192CL) Manman Legacy Diamond Burr Tool 3 mm X 45mm(QR 213 61 07 ) Manman Legacy Shaver Teardrop Cutter 3 x 355(MLSCSB3355M) Manman Legacy Shaver Double Serrated Burr 5 x 250(MLSCDS53250M) Manman Legacy Shaver Teardrop Cutter 3 x 250(MLSCSB3250M) Manman Legacy Shaver Spherical Burr 4 x 192 SN(MLSCSB4192SN) Manman Legacy Shaver Double Serrated Burr 5 x 192 (MLSCDS5192M) Manman Legacy Shaver Internal Tooth Burr 3 x 147 SN(MLSCIT3147SN) Manman Legacy Shaver Cylindrical Burr 3 x 147(MLSCCB3147M) Manman Legacy Shaver Double Serrated Burr 4 x 192 (MLSCDS4192M) Manman Legacy Shaver Cylindrical Burr 4 x 187 S(MLSCCB4187S) Manman Legacy Shaver Toothless Cutter 5 x 192 SN(MLSCTLC5192SN) Manman Legacy Cutting Burr Tool 6 mm X 200mm(QR 213 66 05 ) Manman Legacy Shaver Cylindrical Burr 3 x 147 SN(MLSCCB3147SN) Manman Legacy Shaver Toothless Cutter 4 x 192 (MLSCTLC4192M) Manman Legacy Shaver Spherical Burr 4 x 187 S(MLSCSB4187S) Manman Legacy Shaver Spherical Burr 5 x 147(MLSCSB5147M) Manman Legacy Diamond Burr Tool 5 mm X 200mm(QR 213 66 09 ) Manman Legacy Diamond Burr Tool 4 mm X 75 mm(QR2130903) Manman Legacy Shaver Spherical Burr 3 x 192 CL(MLSCSB3192CL) Manman Legacy Shaver Double Serrated Burr 4 x 147 SN(MLSCDS4147SN) Manman Legacy Shaver Cylindrical Burr 5 x 355(MLSCCB5355M) Manman Legacy Shaver Teardrop Cutter 5 x 147 SN(MLSCSB5147SN) Manman Legacy Shaver Double Serrated Burr 3 x 147(MLSCDS3147M) Manman Legacy Shaver Teardrop Cutter 3 x 192 (MLSCSB3192M) Manman Legacy Shaver Double Serrated Burr 4 x 187 S(MLSCDS4187S) Manman Legacy Shaver Cylindrical Burr 5 x 192 SN(MLSCCB5192SN) Manman Legacy Shaver Spherical Burr 5 x 192 (MLSCSB5192M) Manman Legacy Shaver Teardrop Cutter 55 x 187 S(MLSCSB55187S) Manman Legacy Shaver Internal Tooth Burr 3 x 355(MLSCIT3355M) Manman Legacy Shaver Double Serrated Burr 4 x 147(MLSCDS4147M) Manman Legacy Shaver Cylindrical Burr 4 x 192 SN(MLSCCB4192SN) Manman Legacy Shaver Toothless Cutter 5 x 147 SN(MLSCTLC5147SN) Manman Legacy Cutting Burr Tool 5 mm X 200mm(QR 213 66 04 ) Manman Legacy Shaver Internal Tooth Burr 3 x 187 S(MLSCIT3187S) Manman Legacy Shaver Cylindrical Burr 3 x 250(MLSCCB3250M) Manman Legacy Shaver Cylindrical Burr 4 x 192 CL(MLSCCB4192CL) Manman Legacy Shaver Toothless Cutter 5 x 187 A(MLSCTLC53187A) Manman Legacy Diamond Burr Tool 3 mm X 200mm(QR 213 66 07 ) Manman Element BCDR Multidrive HP(E21160100) Manman Legacy Shaver Teardrop Cutter 3 x 192 SN(MLSCSB31927SN) Manman Legacy Shaver Double Serrated Burr 5 x 147 SN(MLSCDS5147SN) Manman Legacy Shaver Toothless Cutter 5 x 147(MLSCTLC5147M) Manman Legacy Shaver Spherical Burr 4 x 250(MLSCSB4250M) Manman Legacy Shaver Teardrop Cutter 4 x 187 A(MLSCSB4187A) Manman Legacy Shaver Teardrop Cutter 5 x 192 (MLSCSB5192M) Manman Legacy Diamond Burr Tool 5 mm X 45mm(QR 213 61 09 ) Manman Legacy Shaver Spherical Burr 3 x 192 SN(MLSCSB3192SN) Manman Legacy Shaver Teardrop Cutter 4 x 147 SN(MLSCSB4147SN) Manman Legacy Shaver Cylindrical Burr 5 x 147(MLSCCB5147M) Manman Legacy Shaver Cylindrical Burr 3 x 192 SN(MLSCCB3192SN) Manman Legacy Shaver Toothless Cutter 4 x 250(MLSCTLC4250M) Manman Legacy Shaver Spherical Burr 4 x 187 A(MLSCSB4187A) Manman Legacy Diamond Burr Tool 6 mm X 200mm(QR 213 66 10 ) Manman Legacy Diamond Burr Tool 3 mm X 120 mm(QR2131302) Manman Legacy Shaver Spherical Burr 3 x 187 S(MLSCSB3187S) Manman Legacy Shaver Teardrop Cutter 4 x 192 SN(MLSCSB4192SN) Manman Legacy Shaver Cylindrical Burr 5 x 192 (MLSCCB5192M) Manman Legacy Shaver Teardrop Cutter 5 x 250(MLSCSB5250M) Manman Legacy Shaver Cylindrical Burr 3 x 187 S(MLSCCB3187S) Manman Legacy Shaver Toothless Cutter 4 x 355(MLSCTLC4355M) Manman Legacy Shaver Spherical Burr 4 x 192 CL(MLSCSB4192CL) Manman Legacy Cutting Burr Tool 2 mm X 45mm (QR 213 61 01 ) Manman Legacy Diamond Burr Tool 5 mm X 120 mm(QR2131304) Manman Legacy Shaver Spherical Burr 3 x 187 A(MLSCSB3187A) Manman Legacy Shaver Double Serrated Burr 4 x 355(MLSCDS4355M) Manman Legacy Shaver Teardrop Cutter 4 x 187 S(MLSCSB4187S) Manman Legacy Shaver Cylindrical Burr 5 x 250(MLSCCB5250M) Manman Legacy Shaver Teardrop Cutter 5 x 355(MLSCSB5355M) Manman Legacy Shaver Cylindrical Burr 3 x 187 A(MLSCCB3187A) Manman Legacy Shaver Spherical Burr 3 x 192 (MLSCSB3192M) Manman Legacy Shaver Toothless Cutter 4 x 147 SN(MLSCTLC4147SN) Manman Legacy Shaver Teardrop Cutter 4 x 147(MLSCSB4147M) Manman Legacy Diamond Burr Tool 4 mm X 95 mm(QR2131103) Manman Legacy Shaver Teardrop Cutter 3 x 147 SN(MLSCSB3147SN) Manman Legacy Shaver Double Serrated Burr 5 x 355(MLSCDS5355M) Manman Legacy Shaver Spherical Burr 4 x 147 SN(MLSCSB4147SN) Manman Legacy Shaver Double Serrated Burr 5 x 147(MLSCDS5147M) Manman Legacy Multidrive Handpiece(QR2130001) Manman Legacy Shaver Double Serrated Burr 3 x 192 (MLSCDS3192M) Manman Legacy Shaver Double Serrated Burr 4 x 187 A(MLSCDS4187A) Manman Legacy Shaver Cylindrical Burr 55 x 187 S(MLSCCB55187S) Manman Legacy Shaver Spherical Burr 5 x 250(MLSCSB5250M) Manman Legacy Shaver Teardrop Cutter 5 x 187 A(MLSCSB5187A) Manman Legacy Shaver Double Serrated Burr 3 x 192 CL(MLSCDS3192CL) Manman Legacy Shaver Spherical Burr 4 x 192 (MLSCSB4192M) Manman Legacy Shaver Teardrop Cutter 5 x 147(MLSCSB5147M) Manman Legacy Diamond Burr Tool 4 mm X 45mm(QR 213 61 08 ) Manman Legacy Shaver Cylindrical Burr 3 x 192 CL(MLSCCB3192CL) Manman Legacy Shaver Spherical Burr 3 x 250(MLSCSB3250M) Manman Legacy Shaver Teardrop Cutter 4 x 192 (MLSCSB4192M) Manman Legacy Cutting Burr Tool 6 mm X 120 mm(QR2131309) Manman Legacy Shaver Spherical Burr 3 x 147(MLSCSB3147M) Manman Legacy Shaver Spherical Burr 3 x 355(MLSCSB3355M) Manman Legacy Shaver Teardrop Cutter 4 x 250(MLSCSB4250M) Manman Legacy Cutting Burr Tool 5 mm X 120 mm(QR2131308) Manman Legacy Shaver Internal Tooth Burr 3 x 187 A(MLSCIT3187A) Manman Legacy Shaver Cylindrical Burr 3 x 355(MLSCCB3355M) Manman Legacy Shaver Toothless Cutter 4 x 147(MLSCTLC4147M) Manman Legacy Shaver Toothless Cutter 5 x 192 CL(MLSCTLC5192CL) Manman Legacy Diamond Burr Tool 4 mm X 200mm(QR 213 66 08 ) Manman Legacy Diamond Burr Tool 6 mm X 120 mm(QR2131305) Manman Legacy Shaver Double Serrated Burr 3 x 187 S(MLSCDS3187S) Manman Legacy Shaver Cylindrical Burr 4 x 355(MLSCCB4355M) Manman Legacy Shaver Toothless Cutter 4 x 192 CL(MLSCTLC4192CL) Manman Legacy Shaver Spherical Burr 5 x 187 A(MLSCSB5187A) Manman Legacy Diamond Burr Tool 2 mm X 45mm (QR 213 61 06 ) Manman Legacy Shaver Double Serrated Burr 3 x 147 SN(MLSCDS3147SN) Manman Legacy Shaver Cylindrical Burr 4 x 192 (MLSCCB4192M) Manman Legacy Shaver Toothless Cutter 4 x 187 S(MLSCTLC4187S) Manman Legacy Shaver Spherical Burr 5 x 192 SN(MLSCSB5192SN) MANMAN LEGACY ANGULAR BURR ATTACHMENT 200 MM (QR 213 69 00) Manman Legacy Cutting Burr Tool 5 mm X 45mm(QR 213 61 04 ) Manman Legacy Shaver Internal Tooth Burr 3 x 192 SN(MLSCIT3192SN) Manman Legacy Shaver Cylindrical Burr 3 x 192 (MLSCCB3192M) Manman Legacy Shaver Double Serrated Burr 4 x 250(MLSCDS43250M) Manman Legacy Shaver Cylindrical Burr 4 x 187 A(MLSCCB4187A) Manman Legacy Shaver Toothless Cutter 55 x 187 S(MLSCTLC55187S) Manman Legacy Diamond Burr Tool 2 mm X 200mm (QR 213 66 06 ) Manman Legacy Shaver Double Serrated Burr 3 x 250(MLSCDS3250M) Manman Legacy Shaver Double Serrated Burr 4 x 192 CL(MLSCDS4192CL) Manman Legacy Shaver Cylindrical Burr 5 x 187 A(MLSCCB5187A) Manman Legacy Shaver Spherical Burr 5 x 355(MLSCSB5355M) Manman Legacy Shaver Teardrop Cutter 5 x 192 CL(MLSCSB5192CL) Manman Legacy Cutting Burr Tool 3 mm X 45mm(QR 213 61 02 ) Manman Legacy Shaver Double Serrated Burr 3 x 355(MLSCDS3355M) Manman Legacy Shaver Cylindrical Burr 4 x 147(MLSCCB4147M) Manman Legacy Shaver Toothless Cutter 4 x 192 SN(MLSCTLC4192SN) Manman Legacy Shaver Cylindrical Burr 5 x 192 CL(MLSCCB5192CL) Manman Legacy Shaver Spherical Burr 5 x 147 SN(MLSCSB5147SN) MANMAN LEGACY STRAIGHT BURR ATTACHMENT 200 MM(QR 213 65 00) Manman Legacy Cutting Burr Tool 4 mm X 45mm(QR 213 61 03 ) Manman Legacy Shaver Internal Tooth Burr 3 x 192 CL(MLSCIT3192CL) Manman Legacy Shaver Teardrop Cutter 3 x 147(MLSCSB3147M) Manman Legacy Shaver Double Serrated Burr 4 x 192 SN(MLSCDS4192SN) Manman Legacy Shaver Cylindrical Burr 5 x 147 SN(MLSCCB5147SN) Manman Legacy Shaver Teardrop Cutter 5 x 192SN(MLSCSB5192SN) Manman Legacy Shaver Double Serrated Burr 3 x 192 SN(MLSCDS3192SN) Manman Legacy Shaver Cylindrical Burr 4 x 250(MLSCCB4250M) Manman Legacy Shaver Toothless Cutter 4 x 187 A(MLSCTLC43187A) Manman Legacy Shaver Spherical Burr 55 x 187 S(MLSCSB55187S) Manman Legacy Cutting Burr Tool 2 mm X 200mm (QR 213 66 01 ) Manman Legacy Cutting Burr Tool 6 mm X 45mm(QR 213 61 05 ) Manman Legacy Shaver Internal Tooth Burr 3 x 192 (MLSCIT3192M) Manman Legacy Shaver Teardrop Cutter 3 x 187 A(MLSCSB3187A) Manman Legacy Shaver Double Serrated Burr 55 x 187 S(MLSCDS55187S) Manman Legacy Shaver Toothless Cutter 5 x 250(MLSCTLC5250M) Manman Legacy Cutting Burr Tool 3 mm X 200mm(QR 213 66 02 ) Manman Legacy Shaver Internal Tooth Burr 3 x 250(MLSCIT3250M) Manman Legacy Shaver Teardrop Cutter 3 x 192 CL(MLSCSB3192CL) Manman Legacy Shaver Cylindrical Burr 4 x 147 SN(MLSCCB4147SN) Manman Legacy Shaver Double Serrated Burr 5 x 187 A(MLSCDS5187A) Manman Legacy Shaver Toothless Cutter 5 x 355(MLSCTLC5355M) Manman Legacy Cutting Burr Tool 4 mm X 200mm(QR 213 66 03 ) Manman Bi-Portal Endoscopic Tissue Dissector(MBS2220700) Manman Bi-Portal Endoscopic Working Sleeve 1045(MBS2222000) Manman Bi-Portal Endoscopic Working Sleeve 1265(MBS2222600) Manman Transfer Tube(MS1010000) Manman Bi-Portal Endoscopic Working Sleeve 845(MBS2221600) Manman Allen Key 3 mm(MAK3) Manman Bi-Portal Endoscopic Working Sleeve 1035(MBS2221900) Manman Bi-Portal Endoscopic Working Sleeve 1055(MBS2222100) Manman Bi-Portal Endoscopic Working Sleeve 835(MBS2221500) Manman Allen Key 2 mm(MAK2) Manman Bi-Portal Endoscopic Working Sleeve 865(MBS2221800) Manman Bi-Portal Endoscopic Working Sleeve 1065(MBS2222200) Manman Bi-Portal Endoscopic Autoclave Box(MBS2222700) Manman Bi-Portal Endoscopic Working Sleeve 1255(MBS2222500) Manman Bi-Portal Endoscopic Working Sleeve 855(MBS2221700) Manman Bi-Portal Endoscopic Working Sleeve 1235(MBS2222300) Manman Bi-Portal Endoscopic Working Sleeve 1245(MBS2222400) Manman Bi-Portal Endoscopic Lacerator (Indian Knife)(MBS2220600) Manman Bi-Portal Endoscopic Sheath(MBS2221400) Manman Bi-Portal Endoscopic Osteotome Straight(MBS2221100) Manman Bi-Portal Endoscopic Angled Osteotome Rh(MBS2221300) Manman Bi-Portal Endoscopic Angled Osteotome Lh(MBS2221200) Manman BCDR Electrical Flexible Shaft 1.5Mtr(I1720000) Manman Swift V3 Battery Operated Reciprocating Saw Handpiece(SR2200000) Manman Swift V3 Sagittal Saw Handpiece(V32120000) Manman BCDR Electrical Reciprocating Saw Blade(G21400100) Manman Multi Attachment Handpiece Drilling Attachment(MV2030300) Manman Legacy Power Console(QR2133400) Manman USB C PD Charger(E2PSA45) Manman Legacy Foot Control(QR2133200) Manman BCDR Electrical Perforator Handpiece(R1470000) Manman BCDR Electrical Resternotomy (Redo) Saw Handpiece(P1520000) Manman Legacy Adult Craniotome Attachment(QR2133900) Manman NXG Battery Operated Reaming Handpiece(DVNXMD2360000  ) Manman BCDR Electrical Paediatric Sternum Saw Handpiece (O11680000) Manman Swift V3 Battery Operated Sternum Saw handpiece anchor adult(SO2140200) Manman Multi Attachment Handpiece Reaming Attachment AO Quick Coupling 400(MV2030400) Manman Legacy Straight Perforator Attachment(QR2133500) Manman BCDR Electrical Saggital Saw Blade Set (Set of 5) (G1380015) Manman Swift V3 Sagittal Saw Blade Set (Set of 7)(SS2100700) Manman Swift V3 Charger(V32111500) Manman BCDR Electrical Foot Control 220W(A1710600) Manman BCDR Electrical Reciprocating Saw Handpiece(G21400000) Manman Legacy Sagittal Saw Attachment (QR 213 67 00) Manman BCDR Electrical Transverse Saw Handpiece(H1510000) Manman Legacy Sagittal Sagittal Saw Blade set(QR 213 68 01) Manman Swift V3 Battery Operated Sternum Saw Handpiece(SO2140000) Manman Swift V3 Battery Operated Multidrive Handpiece(V32110000) Manman BCDR Electrical Perforator Handpiece Hudson End(RH2190000) Manman Swift V3 Saggital Saw Blade Set (Set of 7) (SS2100700) Manman BCDR Electrical Craniotome Handpiece(Q1540000) Manman Swift V3 Battery Operated Resternotomy Saw Handpiece(SR2150000) Manman Element BCDR Sagittal Saw Hand piece(E21170000) Manman Swift V3 Power Console(V32111200) Manman Swift V3 Battery Operated Multi Drive Handpiece Double Trigger(V32310000) Manman Autopsy Saw System Electrical (Mains)(AS2240000) Manman Plaster Cutter Blade Set (Set of 3)(Pc1500003) Manman BCDR Electrical Pistol Grip Sagittal Saw Handpiece(PG1390000) Manman Battery operated NXG 1200 Handpiece(DVNXMD2350000) Manman BCDR Electrical Sternum Saw Handpiece (O1670000) Manman BCDR Electrical Reciprocating Saw Blade Dual Cutting(G21400200) Manman BCDR Resternotomy (Redo) Saw Blade Set(P1520016) Manman Bi-Portal Endoscopic Ball Tip Probe(MBS2220300) Manman Bi-Portal Endoscopic Double Ended Probe(MBS2220500) Manman Bi-Portal Endoscopic Sharp Hook(MBS2220400)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2023-10-17
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2023-10-17
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2023-10-17
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2024-12-28
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-10-17
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2024-12-28
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-12-28
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2024-12-28
HAB Saw, Powered, And Accessories General, Plastic Surgery Class 1 878.4820 2023-10-17
HXB Probe Orthopedic Class 1 888.4540 2024-12-28

Official Correspondent

Siddharth Gokhale

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: info@mdiconsultants.com Phone: (570) 1516482

Related Public Records

Same Entity

Manman Manufacturing Company Private Limited
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
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-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011 Depuy Orthopaedics, Inc. 1
Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013893019. Last updated year: 2026. Please use registration number 3013893019 when referencing this establishment in official correspondence.
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