510(k) clearances

Freedom® Total Knee System - Porous Tibial Base Plate

Maxx Orthopedics, Inc. · Orthopedic

K241597Substantially EquivalentTraditionalMBH
Open FDA's page for this record
Third party flag
N
City
Norristown
Advisory committee description
Orthopedic
Address 1
2460 General Armistead Ave. Suite 100
Statement or summary
Summary
Product code
MBH
Zip code
19403
Applicant
Maxx Orthopedics, Inc.
Decision date
2025-02-13
Decision code
SESE
Country code
US
Device name
Freedom® Total Knee System - Porous Tibial Base Plate
Advisory committee
OR
Contact
Corey Perine
K number
K241597
State
PA
Date received
2024-06-03
Review advisory committee
OR
Postal code
19403
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Medical specialty description
Orthopedic
Regulation number
888.3565
Device class
2
Registration number
9610612, 2648920, 3008868758, 1822565, 3002579136, 1057425, 8043792, 3010287737, 3014302784, 3014833750, 3021008900, 3016090213, 1835572, 3006356043, 3004450489, 1226544, 3010856250, 3007366790, 3008262872, 3002806603, 3006801265, 3010047402, 3005180920, 2244478, 1644408, 3012491394, 2134285, 3012392319, 3009887475, 3030412764, 3003477135, 3015806723, 3010065126, 9613350, 3004976965, 3020155054, 3008395353, 3033509898, 3006017180, 3009760038 +182 more
FEI number
3008868758, 3002579136, 3014833750, 3014302784, 3010287737, 3021008900, 3008342029, 3002807036, 3016090213, 3006356043, 3004450489, 3002993297, 3010856250, 3008262872, 3002806603, 3006801265, 3010047402, 3005180920, 3003058119, 1000139987, 3002808269, 3012491394, 3002807172, 3012392319, 1000199976, 3007282753, 3009887475, 3003015552, 3030412764, 3003477135, 1000143502, 3015806723, 3010065126, 3004976965, 3020155054, 3003386935, 3008395353, 3033509898, 3006017180, 3009760038 +182 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.