FDA Registration
Active
🇺🇸 United States
TOPMED MEDICAL DEVICES INC
Reg #: 3039169546
·
FEI: 3039169546
·
Expires 2026
Products
16
Proprietary Names
440
Establishment Types
3
Classifications
16
Registration Details
- Registration Name
- TOPMED MEDICAL DEVICES INC
- Registration Number
- 3039169546
- FEI Number
- 3039169546
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 16 Goddard
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221745
Owner / Operator
- Firm Name
- Topmed Medical Devices Inc
- Operator Number
- 10093458
- Address
- 2 GODDARD
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2026-03-19 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2026-03-19 |
| Probe | HXB | Class 1 | Orthopedic | No | 2026-03-19 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2026-03-19 |
| Motor, Surgical Instrument, Pneumatic Powered | GET | Class 1 | General, Plastic Surgery | No | 2025-06-22 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2026-03-19 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-12-26 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2026-03-19 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2026-03-19 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2026-03-19 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2026-03-19 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2026-03-19 |
| Bender | HXW | Class 1 | Orthopedic | No | 2026-03-19 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2026-03-19 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2026-03-19 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2025-06-22 |
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
Screw Driver
Counter Torque
Dilator
Hex Driver & Screw Adjustable Driver
Pedicle Finder
Plug Driver&Screw Adjustable Driver
Rod Bender
Circular Position Needle
Test Rod
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
Distractor
Support Block
Two-way Distractor
Distractor & Compressor
Compressor
Posterior Spinal Fixation System
Rod Bender 325
Cannulated Screw Tap 6
Cannulated Screw Tap 5
Screw Tap 4
Screw Tap 6
Screw Tap 5
Cannulate Conversion Wrench + Hexagonal Wrench
Screw Counter Wrench
Blade Breaking Wrench
Crosslink Inner Hex Driver
Torx Wrench
Torx Locking Wrench
T Ratchet Handle
Counter Torque Wrench
Tap Breaker
Screw Conversion Wrench
Rod Rotate Wrench
Oval Handle
T Handle
Screw Counter Torque
2in1 Polyaxial screw driver
Wrench
EPM Mueller LTC.
MIS And Mini
Reamer
Reamer ST
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device