510(k) clearances

A.L.P.S. Small Fragment Plating System

Biomet Orthopedics · Orthopedic

K243761Substantially EquivalentTraditionalHRS
Open FDA's page for this record
Third party flag
N
City
Warsaw
Advisory committee description
Orthopedic
Address 1
56 E Bell Dr.
Statement or summary
Summary
Product code
HRS
Zip code
46581
Applicant
Biomet Orthopedics
Decision date
2025-02-19
Decision code
SESE
Country code
US
Device name
A.L.P.S. Small Fragment Plating System
Advisory committee
OR
Contact
Tracy Johnson
K number
K243761
State
IN
Date received
2024-12-06
Review advisory committee
OR
Postal code
46581
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Plate, Fixation, Bone
Medical specialty description
Orthopedic
Regulation number
888.3030
Device class
2
Registration number
3011580264, 1226544, 3023265483, 9614438, 3007051929, 3006801265, 3010047402, 3007993775, 3013280419, 3038503572, 3014527928, 3019923333, 1058084, 3010400367, 9615766, 3010470577, 2032830, 3004187715, 3022777867, 3021336182, 2031009, 3015869121, 3011230048, 3043543260, 3011295718, 3026576110, 3010375065, 3010646402, 2531477, 3036756245, 3034676720, 1218017, 3010039400, 3013540005, 3011127597, 1828288, 1038671, 3005751028, 3027242374, 3009756327 +481 more
FEI number
3011580264, 3023265483, 3007051929, 3006801265, 3010047402, 3007993775, 1000139987, 1000069183, 3013280419, 3038503572, 3007282753, 3014527928, 3019923333, 3002807231, 3002808264, 1000143502, 3003690049, 3010400367, 3010470577, 3004187715, 3022777867, 3008782585, 3021336182, 3015869121, 3011230048, 3043543260, 3011295718, 3026576110, 3010375065, 3010646402, 3002821504, 3036756245, 3034676720, 1218017, 3010039400, 3013540005, 3011127597, 1828288, 1038671, 3005751028 +481 more
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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.