Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039169546

FEI Number

3039169546

Entity Name

TOPMED MEDICAL DEVICES INC

City/State/Country

Irvine, CA, US

Establishment Address

16 Goddard, Irvine, CA 92618, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Topmed Medical Devices Inc (Owner Number: 10093458)

Owner / Operator Contact Address

2 GODDARD, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dilator 16.2 Persuader Sleeve Inner Tube Dilator 13 Dilator 14.5 Persuader Outer Tube Dilator 6 Set Screw Case Instrument Box Instrument box Double-headed Probe Straight Probe Awl Cannulated Awl Thoracic Vertebra Awl Curved Pedicle Finder Straight Pedicle Finder TM5102 Bone Dril TM1107B1(36-64)ACETABULUM REAMER TM3601 TM3602-II-70 TMS2011 Aseptic Transfer Kit TM6602 TM2107D CANNULATE DRILL ATTACHMENT TM6603S TM4303B DUAL FUNCTION CANNULATE DRILL TM8402 Bone Drill Atachment TM1103B1 (7-14)MEDULLARY REAMER: Topmed Coupling TM8401 Sagittal Saw Attachment TM4213A K-WIRE DRILL ATTACHMENT TM3500 Power tool TM3502 Straight Attachment TM3602-II-110 TM2003 LID TM4102 BONE DRILL TMRJ-MP Multifunctional Handpiece TM12002 CHARGER TMPJDC1481 Battery TM5201 Sagittal Saw Attachment TM37012 TM6203 CANNULATE DRILL ATTACHMENT TM14004 ASEPTIC TRANSFER KIT TM5501 Sagittal Saw TM5507B Acetabulum Reaming Drill High Torgue TM5607S Acetabulum Reaming Drll Attachment TM5402 Bone Drill Attachment TM6603 TM5107D Acetabulum Reaming Drill TM6207B ACETABULUM REAMING DRILL ATTACHMENT TM43005 Key TM8102 BONE DRILL TM4407B Acetabulum Reaming Drill Attachment TM1107D1L REAMER SHAFT TM5203D Cannulated Drill Attachment TM6004-2 ASEPTIC TRANSFER KIT TMPJBB001 Battery Sterilizing Box TM1103B DUAL FUNCTION CANNULATE DRILL TM32012(1-6) DIAMOND DRILL BIT TM6602S TM1003 LID TMXXZ-2-20-70 MILLING BUR Pneumatic Powered - 300MM GUIDE WIRES (NON-IMPLANTABLE) TM4109 RECIPROCATING SAW TMPJXD004 Transfer Kit TMNM1 Adatper TM3407 SMART DRILL-SLOW(NEW) TM4102A DUAL FUNCTION BONE DRILL TM54002 Charger TM1103D DUAL FUNCTION CANNULATE DRILL TM4402 CANNULATE BONE DRILL ATTACHMENT TM4106 STERNUM SAW TMXXZ-2-9-65 MILLING BUR TM4309 RECIPROCATNGSAW FOR SURGERY OPERATION TM5407D Acetabulum Reaming Drill Attachment TM34002 CHARGER TM8200 MULTI FUNCTION HANDPIECE TMXZ-3 1/4.1-12.5-65 MILLING BUR TMPJDB011 Sterilization Case TM43003 Battery Sterilization Container TM36006 TM5509 Reciprocating Saw TM53002 Charger TM5501-II Sagittal Saw TM3609 TM1002-4 MULTI-FUNCTION CHARGER TM14001 BATTERY TM4402 Bone Drill Attachment TMNM5 Adatper TM6607B TM4400 MULTI-FUNCTION HANDPIECE TM1002 CHARGER TM6600 TM43001 BATTERY TM2112 TPLO ATTACHMENT TM5503B Cannulated Drill TM5306 Sternum Saw TM4302 BONE DRILL FOR JOINT PROCEDURES TM6602D TM1103S1(7-14)MEDULLARY REAMER(HUDSON) TM8403 Cannulated Drill Attachment TM8201 SAGITTAL SAW ATTACHMENT TM5209 Reciprocating Saw Attachment TM6613A TM1407B ACETABULUM REAMING DRILL TM4402SAO CANNULATE AO BONE DRILL ATTACHMENT TM5802 Dual Drill/Ream Attachment TM14002 CHARGER TM84005 Multi Charger TM6602SAO TM8203 CANNULATED DRILL ATTACHMENT TM6601 TM1102A DUAL FUNCTION BONE DRILL TM2111 TORQUE LIMITER ATTACHMENT TM5202 Bone Drill Attachment TM2106 STERNUM SAW ATTACHMENT TM4207D ACETABULUM REAMING DRILL ATTACHMENT FOR JOINT PROCEDURES TM8418 Oscillating Saw Attachment TMRJ-PD Drill TM54003 Battery Case TMSU11004 Aseptic Transfer Kit TMS4112 Battery TMXZ-2-12-65 MILLING BUR TMPJCG002 Charger TM8402SA0 AO Drill Attachment TM5802SA0 Small AO Quick Coupling TM5802S Dual Drill/Ream Attachment TM4107D DUAL-FUNCTION ACETABULUM REAMING DRILL TMRJ-PS Saw Handpiece TM4301 SAGITTAL SAW TM8103 CANNULATED DRILL TM3602-II-45 TM11061 PROTECTION OF SUPPORT TM1101 SAGITTAL SAW TM35012 Foot Control TM8402S Hudson Bone Drill Attachment TM2102 BONE DRILL ATTACHMENT TM4107 ACETABULUM REAMING DRILL TM5800 Multi-Functional Handpiece TMXXZ-2.7/3.1-12.5-65 MILLING BUR TM5507D Acetabulum Reaming Drill TM35016 Power adaptor TM1108 OVERHAUL SAW TM5403D Cannulated Drill Attachment TM6007 CONNECTION WIRE TM4004 ASEPTIC TRANSFER KIT TM54004 Aseptic transfer kit TM4407S STRYKER CANNULATE ACETABULUM DRILL ATTACHMENT TM2103 CANNULATE DRILL ATTACHMENT TMXXZ-2.7-13.5-65 MILLING BUR TM4402SAO AO Drill Atachment TM1102 BONE DRILL TM4108 OVERHAUL SAW TMPJDC0741 Battery TM4403D Cannulated Drill Attachment TMPJDB002 Sterilization Case TM4207B ACETABULUM REAMING DRILL TMPJCG001 Charger TMXXZ-3-8-65 MILLING BUR TM5109 Reciprocating Saw TMSU11002 Charger TM43002-4B MULTI-FUNCTION CHARGER TM34001 BATTERY TMSM1 Adatper TM3600 TMPJCG007 Charger TM1001 BATTERY TM5607D Acetabulum Reaming Drill Attachment TM3401 SMART SAW (NEW) TM8400 Muti-Functional Handpiece TM-S5001 Battery TM1201-III ELECTRIC CAST CUTTER WITH VACUUM CLEANER TM5607B Acetabulum Reaming Drill Attachment TM3603-II-70 TM35006 Power Adaptor TM5400 + TM5413 K-Wire Driver TM8209 RECIPROCATING SAW ATTACHMENT TM43003 BATTERY STERILIZATION CONTAINER TM37006 TM2101S STRYKER SAGITTAL SAW ATTACHMENT TM8413A K-Wire Driver Attachment TM4101 SAGITTAL SAW TM4213B K-WIRE DRILL ATTACHMENT TM4402S STRYKER CANNULATE BONE DRILL TM4202 BONE DRILL ATTACHMENT FOR TRAUMA PROCEDURES TM2103D CANNULATE DRILL ATTACHMENT TMPJCG005 Charger TM4407D Acetabulum Reaming Drill Attachment TM41021SA0(2-4.5)A0 TWIST DRILL BIT TM11021(2-4.5)TWIST DRILL BIT TM1401 SAGITTAL SAW TM4403B Cannulated Drill Attachment TM8113A K-WIRE DRILL TM5207D Acetabulum Reaming Drill Attachment TM6008 BATTERY TM5602 Bone Drill Attachment TM4307B ACETABULUM REAMING DRILL TM6006 POWER CONSOLE TM4203D CANNULATE DRILL ATTACHMENT FOR TRAUMA PROCEDURES TM3207 4:1 Reducer TM2100 MULT-FUNCTION HANDPIECE TM1202 ECONOMICAL BONE DRILL TMRJ-RP TPLO Saw Blade TM1403B DUAFUNCTION CANNULATE DRILL TMXZ-2-20-70 MILLING BUR TMXXZ-2.2/3-21-73.5 MILLING BUR TMPJXD007 Aseptic Transfer Kit TM6107B DUAL-FUNCTION ACETABULUM REAMING DRILL Surgical instrument TM2102SAO AO BONE DRILLATTACHMENT TM6607D TM5202SAO AO Drill Attachment TM34004 ASEPTIC TRANSFER KIT TM6101 SAGITTAL SAW TM1107B ACETABULUM REAMING DRILL TM8101 SAGITTAL SAW TM4003 LID TMXZ-2.7-13.5-65 MILLING BUR TM3513 K-Wire Drill Attachment TM3402 SMART DRILL-FAST(NEW) TM5813 K-Wire Driver TMXXZ-2-13-65 MILLING BUR TM43001 Battery(12V 1300mAh) TM5106 Sternum Saw TMXXZ-3.2/4.5-12-65 MILLING BUR TM53003 Battery Case TM43002 CHARGER TM6603D TM2101 SAGITTAL SAW ATTACHMENT TM2107B ACETABULUM REAMING DRILL ATTACHMENT TM5200 Multi Function Handpiece TM6103B DUAL FUNCTION CANNULATED DRILL TM5107B Acetabulum Reaming Drill TM1201S MEDICAL ELECTRIC PLASTER CUTTING SAW TM4102SAO AO DRILL TM8113B K-WIRE DRILL TM2110 TORQUE LIMITER ATTACHMENT TMXXZ-2-20-100 MILLING BUR TMXZ-4-30-65 MILLING BUR TM8202SAO AO DRILL ATTACHMENT Standard Offset TM4103 CANNULATE DRILL TM6003 LID TMNM3 Adatper TM2109 RECIPROCATING SAW ATTACHMENT TM84004 Aseptic Transfer Kit TM53001 Battery(9.6V 1800mAh) TM32011(1-6) CUTTING DRILL BIT TMXZ-2-22.5-65 MILLING BUR TM9800 TMPJDB008 Sterilization Case TM12011 FLAT WRENCH TM4107B DUAL-FUNCTION ACETABULUM REAMING DRILL TM4202SAO AO DRILL ATTACHMENT FOR TRAUMA PROCEDURES TM1004 ASPETIC TRANSFER KIT TMPJDC0120 Battery TM53002-4 Multi-Charger TM4200 MULTIFUNCTION HANDPIECE TM1103D1(7-14)MEDULLARY REAMER TM12001 BATTERY TM5207B/TM5207S Acetabulum Reaming Drill Attachment TM5403B Cannulated Drill Attachment TM5103D Cannulated Drill TM6200 MULTI FUNCTION HANDPIECE TM4407B CANNULATE ACETABULUM DRILL ATTACHMENT TM4001 BATTERY TM5613 K-Wire Driver Attachment TM35007 Power Line TM6602B TMPJXD005 Aseptic Transfer Kit Zimmer coupling TM84003 Battery Case TM4413B (2-3) K-Wire Drill Attachment TM1107D1T DETACHABLE AND LENGTHENED TM5400 Multi-Function Handpiece Pneumatic Powered - 900MM GUIDE WIRES (NON-IMPLANTABLE) TM8409 Reciprocating Saw Attachment TM43005 KEY TM3507SA0 Small A0 Coupling Drill Attachment(16: 1) TM2113B K-WIRE DRILL ATTACHMENT TM11081 OVERHAUL SAW BLADE TM4103B DUAL FUNCTION CANNULATE DRILL TM2103B CANNULATE DRILL ATTACHMENT TMXXZ-2-8-65 MILLING BUR TM8002 CHARGER TM1107D1(36-64)ACETABULUM REAMER TM6004-1 ASEPTIC TRANSFER KIT TM5101 Sagittal Saw TMXXZ-1.6/2.3-20-74 MILLING BUR TM-S5002-4 Multi-Charger TM84001 Battery TM3603-II-45 TM5600 Multi Function Handpiece TM6201 SAGITTAL SAW ATTACHMENT TM1402 BONE DRILL TM8001 BATTERY TM4201 SAGITTAL SAW ATTACHMENT FOR JOINTPROCEDURES TMXZ-2.5-30-65 MILLING BUR TM5103B Cannulated Drill TM5301 Sagittal Saw TM1102A6 JACOB CHUCK TM6613B TM1103 CANNULATE DRILL TM1107B1T DETACHABLE AND LENGTHENED TM4403B CANNULATE DRILL ATTACHMENT BLADE TM4407D CANNULATE ACETABULUM DRILL ATTACHMENT TM8413B K-Wire Driver Attachment TM4103D DUAL FUNCTION CANNULATE DRILL TM5206 Sternum Saw Attachment TM6001 BATTERY Diamond Ground TM4300 MULTI-FUNCTION HANDPIECE TM5402SA0 AO Drill Attachment TM5411 Torque limiter TMXXZ-1.2/2.3-12.5-65 MILLING BUR TMRJ-RP Aluminum Case TM3618 TM43004 ASEPITIC TRANSFER KIT TMH1101-II TPLO saw TM5402B High speed Bone Drill Attachment TMXXZ-4-8-65 MILLING BUR TMS2002-2 Charger TM5602SAO AO Drill Attachment TM5506 Sternum Saw TM1201 MEDICAL ELECTRIC PLASTER CUTTING SAW TM5203B/TM5203S Cannulated Drill Attachment TMSU11001 Battery TM5407B Acetabulum Reaming Drill Attachment TM8213A K-WIRE DRILL ATTACHMENT TM84002 Charger TM43004 Aseptic Transfer Kit TM1106 STERNUM SAW TM43002-4B Multi-Function Charger TM3517 Angle Transmission Adaptor TM4413A (0.8-2)K-Wire Drill Attachment TMPJXD001 Transfer Kit TM8213B K-WIRE DRILL ATTACHMENT TM5503D Cannulated Drill TM6603B TMSU11003 Battery Case TM1107B1L REAMER SHAFT TM5802D Dual Drill/Ream Attachment TM6009 LID TM54001 Li-Ion Battery TM1109 RECIPROCATING SAW TM4407S Acetabulum Reaming Drill Attachment TM5802B Dual Drill/Ream Attachment TM4203B CANNULATE DRILL ATTACHMENT FOR TRAUMA PROCEDURES TM5213-II K-Wire Driver Attachment Motor TM5400 + TM5402 Bone Drill TM3502SA0 Small AO Coupling Drill Attachment(4:1) TM5413 K-Wire Driver Attachment TM5410 Torque limiter TMXXZ-1.2/2.3-16-65 MILLING BUR TMPJDC1440 Battery TMH1101-III TPLO saw TM8005 KEY TM36012 TM43002 Charger TM1103B8 JACOBCHUCK TM4400 Multi-Function Handpiece TM1302 POPULARIZED BONE DRILL TM6609 TM3501 Sagittal Saw Attachment TMXZ-2-13-65 MILLING BUR TM2113A K-WIRE DRILL ATTACHMENT TM8202 BONE DRILL ATTACHMENT TM3603-II-110 TM6607S TM1005 KEY Offset Spanner+Set Screw Holder (long) Offset Spanner+ Set Screw Holder (short) Rod Holder(L) Rocker Rod Holder Offset Spanner+Set Screw Holder (short) Crosslink Holder Sterile Posterior Spinal Fixation System Rod Pusher Test Rod 300 Rod Measure K-Wire Cylindrical Position Needle Rod Holder Screw Driver Counter Torque Dilator Hex Driver & Screw Adjustable Driver Pedicle Finder Plug Driver&Screw Adjustable Driver Rod Bender Outer Tube Circular Position Needle Test Rod Inner Tube Canulated Screw Tap 5.5 Probe T-Handle Tab Breaker Set Screw Holder Single Use Cannula Compressor & Distractor Torx Driver Ratchet Handle Set Screw Holder & Torx Driver (Short) Cylindrical Locating Ball Locating Pin Guide Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-03-19
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-03-19
HXB	Probe	Orthopedic	Class 1	888.4540	2026-03-19
HWJ	Awl	Orthopedic	Class 1	888.4540	2026-03-19
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2025-06-22
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2026-03-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-12-26
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2026-03-19
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2026-03-19
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-03-19
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-03-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Topmed Medical Devices Inc

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
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

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3001614464	medi-G GMBH	Messkirch Baden-Wurttemberg, DE
3028006458	ClearPoint Neuro Inc.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039169546. Last updated year: 2026. Please use registration number 3039169546 when referencing this establishment in official correspondence.