Atlas FDA

BIOMET FEMORAL LOCKING NAIL SYSTEM

FDA 510(k) clearance K072161 · decided 2007-09-20

Clearance details

K-number
K072161
Device name
BIOMET FEMORAL LOCKING NAIL SYSTEM
Applicant
Biomet Manufacturing Corp
Decision
Substantially Equivalent
Date received
2007-08-06
Decision date
2007-09-20
Days to decision
45 days
Clearance type
Traditional
Product code
HSB
Device class
2
Regulation number
888.3020
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
TI Cann Partl Thd Recon Screw 6.00MM x 65MM; Trauma Fixation Systems, Rx Only; Biomet, 100 recall (Z-2277-2009)EBI, L.P.2009-09-22
TI Cann Partl Thd Recon Screw 6.00MM x 70MM; Trauma Fixation Systems, Rx Only; Biomet, 100 recall (Z-2278-2009)EBI, L.P.2009-09-22
TI Cann Partl Thd Recon Screw 6.00MM x 75MM; Trauma Fixation Systems, Rx Only; Biomet, 100 recall (Z-2279-2009)EBI, L.P.2009-09-22
TI Cann Partl Thd Recon Screw 6.00MM x 80MM; Trauma Fixation Systems, Rx Only; Biomet, 100 recall (Z-2280-2009)EBI, L.P.2009-09-22
TI Cann Partl Thd Recon Screw 6.00MM x 85MM; Trauma Fixation Systems, Rx Only; Biomet, 100 recall (Z-2281-2009)EBI, L.P.2009-09-22
TI Cann Partl Thd Recon Screw 6.00MM x 90MM; Trauma Fixation Systems, Rx Only; Biomet, 100 recall (Z-2282-2009)EBI, L.P.2009-09-22
TI Cann Partl Thd Recon Screw 6.00MM x 95MM; Trauma Fixation Systems, Rx Only; Biomet, 100 recall (Z-2283-2009)EBI, L.P.2009-09-22
Phoenix Cannulated Recon Screw; Ti-Cann PARTL THD Recon Screw Trauma Fixation Systems; Rx recall (Z-2115-2009)EBI, L.P.2009-09-21

PMA approvals by this applicant

RecordFirmDate
Oxford™ Knee System (P010014/S111)Biomet Manufacturing Corp2025-08-07
Oxford Partial Knee System (P010014/S109)Biomet Manufacturing Corp2025-08-07
OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S110)Biomet Manufacturing Corp2025-06-24
Oxford® Partial Knee System (P010014/S107)Biomet Manufacturing Corp2024-11-22
Oxford™ Cementless Partial Knee System (P010014/S105)Biomet Manufacturing Corp2024-11-22
Oxford Partial Knee System (P010014/S108)Biomet Manufacturing Corp2024-11-18
Oxford® Partial Knee System (P010014/S106)Biomet Manufacturing Corp2024-08-19
Oxford Partial Knee (P010014/S104)Biomet Manufacturing Corp2023-04-06