510(k) K082332 · NKB Thoracolumbosacral Pedicle Screw System

NUVASIVE SPHERX SYSTEM

Applicant	Nuvasive, Inc., San Diego CA, US
Decision	Substantially Equivalent, Oct 10, 2008
Received	Aug 14, 2008
Type	Special
FDA record	Open on fda.gov

Recalls that name K082332

Date	Firm and product	Code	Linked 510(k)
Nov 19, 2012	NuVasive Inc Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed
Nov 19, 2012	NuVasive Inc 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Terminated	NKB	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.