510(k) clearances

Extremity Medical External Fixation System

Extremity Medical, LLC · Orthopedic

K241563Substantially EquivalentTraditionalKTT
Open FDA's page for this record
Third party flag
N
City
Parsippany
Advisory committee description
Orthopedic
Address 1
300 Interpace Pkwy.
Address 2
Bldg. A, 2nd Floor
Statement or summary
Summary
Product code
KTT
Zip code
07054
Applicant
Extremity Medical, LLC
Decision date
2025-02-21
Decision code
SESE
Country code
US
Device name
Extremity Medical External Fixation System
Advisory committee
OR
Contact
Mary Hoffman
K number
K241563
State
NJ
Date received
2024-05-31
Review advisory committee
OR
Postal code
07054
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Medical specialty description
Orthopedic
Regulation number
888.3030
Device class
2
Registration number
3009746186, 9610612, 3030966822, 2648920, 3017521423, 3008868758, 1822565, 8020776, 1057425, 8043792, 3013011598, 3015876273, 3014302784, 3015877656, 3011656326, 3010123172, 3003860203, 1835572, 3021008900, 2532027, 1226544, 1528668, 3007366790, 3006801265, 3013194153, 3025141, 3007125392, 3015212339, 3007993775, 3013302242, 3007289093, 3009826895, 2090040, 3017980266, 3009887475, 3000327445, 3011578810, 3026593233, 3010065126, 3004976965 +211 more
FEI number
3009746186, 3030966822, 3000718490, 3017521423, 3008868758, 3015876273, 3013011598, 3014302784, 3015877656, 4224, 3011656326, 3010123172, 3003860203, 3021008900, 3001406084, 3002926812, 3006801265, 3013194153, 3007125392, 3015212339, 3007993775, 1000139987, 3002808269, 3013302242, 3007289093, 3002615969, 3009826895, 1000306303, 3017980266, 3003414678, 3009887475, 3007282753, 3000327445, 3011578810, 3003015552, 3026593233, 3010065126, 3004976965, 3033509898, 3002924544 +211 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.