ClearanceBrief
Company ยท US

Apex Surgical, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2005. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
HTOReamer6
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented4
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 10, 2005K043123APEX MODULAR HA HIP STEM
Apex Surgical, LLC
LPH
Dec 21, 2004K041950APEX K2 HIP SYSTEM
Apex Surgical, LLC
LPH
May 22, 2003K031110APEX MODULAR ACETABULAR CUP
Apex Surgical, LLC
LPH
Nov 27, 2001K012918APEX MODULAR ALUMINA FEMORAL HEAD
Apex Surgical, LLC
LZO
Mar 20, 2001K003923APEX MODULAR ZIRCONIA FEMORAL HEAD
Apex Surgical, LLC
LZO
Aug 4, 2000K000788APEX MODULAR HIP STEM
Apex Surgical, LLC
LPH

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 20, 2004Apex Surgical, LLC
Apex Pilot Shaft 17.5mm
Terminated
HTONone listed
Jul 20, 2004Apex Surgical, LLC
Apex Pilot Shaft 16mm
Terminated
HTONone listed
Jul 20, 2004Apex Surgical, LLC
Apex Pilot Shaft 14.4mm
Terminated
HTONone listed
Jul 20, 2004Apex Surgical, LLC
Apex Pilot Shaft 13mm
Terminated
HTONone listed
Jul 20, 2004Apex Surgical, LLC
Apex Pilot Shaft, 11.5mm
Terminated
HTONone listed
Jul 20, 2004Apex Surgical, LLC
Apex Pilot Shaft, 10mm
Terminated
HTONone listed
Get alerts for these product codes