Atlas FDA

NUVASIVE SPHERX SYSTEM

FDA 510(k) clearance K082332 · decided 2008-10-10

Clearance details

K-number
K082332
Device name
NUVASIVE SPHERX SYSTEM
Applicant
Nuvasive, Inc.
Decision
Substantially Equivalent
Date received
2008-08-14
Decision date
2008-10-10
Days to decision
57 days
Clearance type
Special
Product code
NKB
Device class
2
Regulation number
888.3070
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (K253739)Globus Medical, Inc.2026-05-07
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Recalls involving this device

RecordFirmDate
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0348-2013)NuVasive Inc2012-11-19
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0349-2013)NuVasive Inc2012-11-19
5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0350-2013)NuVasive Inc2012-11-19
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0351-2013)NuVasive Inc2012-11-19
5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0352-2013)NuVasive Inc2012-11-19
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0353-2013)NuVasive Inc2012-11-19
5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0354-2013)NuVasive Inc2012-11-19
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0355-2013)NuVasive Inc2012-11-19
6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0356-2013)NuVasive Inc2012-11-19
6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0357-2013)NuVasive Inc2012-11-19
6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0358-2013)NuVasive Inc2012-11-19
6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0359-2013)NuVasive Inc2012-11-19
6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0360-2013)NuVasive Inc2012-11-19
7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0361-2013)NuVasive Inc2012-11-19
7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0362-2013)NuVasive Inc2012-11-19
7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0363-2013)NuVasive Inc2012-11-19
7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0364-2013)NuVasive Inc2012-11-19
7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0365-2013)NuVasive Inc2012-11-19
7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0366-2013)NuVasive Inc2012-11-19
Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0367-2013)NuVasive Inc2012-11-19
4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0368-2013)NuVasive Inc2012-11-19
4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0369-2013)NuVasive Inc2012-11-19
5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0370-2013)NuVasive Inc2012-11-19
5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0371-2013)NuVasive Inc2012-11-19
5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0372-2013)NuVasive Inc2012-11-19
6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0373-2013)NuVasive Inc2012-11-19
6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0374-2013)NuVasive Inc2012-11-19
6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0375-2013)NuVasive Inc2012-11-19
7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0376-2013)NuVasive Inc2012-11-19
7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0377-2013)NuVasive Inc2012-11-19
7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recall (Z-0378-2013)NuVasive Inc2012-11-19

PMA approvals by this applicant

RecordFirmDate
Simplify® Cervical Artificial Disc (P200022/S016)Nuvasive, Inc.2025-06-05
Simplify® Cervical Artificial Disc (P200022/S017)Nuvasive, Inc.2025-05-29
Simplify Disc (P200022/S012)Nuvasive, Inc.2025-02-18
Simplify Cervical Artificial Disc (P200022/S015)Nuvasive, Inc.2025-02-13
Simplify Cervical Artificial Disc (P200022/S014)Nuvasive, Inc.2024-12-18
Simplify® Cervical Artificial Disc (P200022/S013)Nuvasive, Inc.2024-04-17
Simplify Disc (P200022/S011)Nuvasive, Inc.2023-06-09
Simplify Cervical Artificial Disc (P200022/S010)Nuvasive, Inc.2023-03-15