FDA Registration Active 🇺🇸 United States

MAXX ORTHOPEDICS INC.

Reg #: 3007311878 · FEI: 3007311878 · Expires 2026
Products
30
Proprietary Names
42
Establishment Types
4
Classifications
30

Registration Details

Registration Name
MAXX ORTHOPEDICS INC.
Registration Number
3007311878
FEI Number
3007311878
Status
Active
Expiry Year
2026
Initial Importer
No
Address
2460 General Armistead Ave, Suite 100
City
Norristown
State
PA
ZIP
19403
Country
US

Regulatory Submissions

510(k) Number
K251717

Owner / Operator

Firm Name
Maxx Orthopedics Inc.
Operator Number
10028575
Address
2460 General Armistead Ave, Suite 100
City
Norristown
State
PA
Postal Code
19403
Country
US

Products

Device Name Product Code
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Extractor HWB
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Driver, Prosthesis HWR
File HTP
Goniometer, Ac-Powered KQX
Screwdriver HXX
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
Broach HTQ
Impactor HWA
Hammer, Surgical FZY
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
Driver, Surgical, Pin GFC
Tape, Measuring, Rulers And Calipers FTY
Tray, Surgical, Instrument FSM
Pliers, Surgical HTC
Reamer HTO
Fork HXE
Guide, Surgical, Instrument FZX
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Orthopedic Manual Surgical Instrument LXH
Starter, Bone Screw HWD
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Bit, Drill HTW
Wrench HXC

Proprietary Names

Freedom Infinia Titanium Tibial Base Plate Freedom Titanium Tibial Base Plate Freedom Metaphyseal Cones Freedom Knee Libertas Hip Freedom All-poly Baseplate Libertas Driver Freedom Driver Infinia Driver Freedom File Infinia File Libertas File TracPatch Knee Freedom Infinia Knee Freedom Porous Tibia Freedom Partial Knee Titan PCK Components Libertas Hammer Infinia Hammer Freedom Hammer Libertas Pin Freedom Pin Infinia Pin Infinia Caliper Libertas Caliper Freedom Caliper Freedom Infinia Infinia Surgical Tray Freedom Surgical Tray Libertas Surgical Tray Freedom Pliers Libertas Pliers Infinia Pliers Libertas Fork Freedom Fork Infinia Fork Freedom Infinia Libertas Bipolar Hip Freedom Bone Screw Infinia Bone Screw Libertas Keystone Hip Stem

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Remanufacture Medical Device