Atlas FDA

MARVEL™ Growing Rods

FDA 510(k) clearance K213196 · decided 2022-12-19

Clearance details

K-number
K213196
Device name
MARVEL™ Growing Rods
Applicant
Globus Medical, Inc.
Decision
Substantially Equivalent
Date received
2021-09-29
Decision date
2022-12-19
Days to decision
446 days
Clearance type
Traditional
Product code
PGM
Device class
2
Regulation number
888.3070
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Audubon, PA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SDS Growing Rod (K251961)BAAT Medical Products B.V.2026-01-15
VerteGlide Spinal Growth Guidance System (K241816)OrthoPediatrics Corp.2025-03-14
Daytona® Small Stature Growth Rod Conversion Set (K193224)SeaSpine Orthopedics Corporation2020-02-13
CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System (K191212)Medos International SARL2019-09-24
CREO® Stabilization System, REVERE® Stabilization System (K181068)Globus Medical, Inc.2018-06-29
Polaris Spinal Growth System (K180227)Zimmer Biomet Spine, Inc.2018-03-15
NuVasive® Growth Rod Conversion Set (K172979)Nu Vasive, Incorporated2017-11-06
K2M Growing Spine System (K161028)K2m, Inc.2016-07-22
CD HORIZON Growth Rod Conversion Set (K150200)Medtronic Sofamor Danek USA, Incorporated2015-02-25
Xia® Growth Rod Conversion Set (K142114)Stryker Corporation2014-10-27
ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS (K141509)Medos Sarl2014-08-22
SHILLA GROWTH GUIDANCE SYSTEM (K140750)Medtronic Sofamor Danek USA, Inc.2014-07-17

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
SECURE®-C Cervical Artificial Disc (P100003/S008)Globus Medical, Inc.2023-06-12
SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S007)Globus Medical, Inc.2017-08-18
SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S006)Globus Medical, Inc.2016-05-17
SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S005)Globus Medical, Inc.2014-12-18
SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S004)Globus Medical, Inc.2014-06-30
SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S003)Globus Medical, Inc.2014-05-08
SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S002)Globus Medical, Inc.2013-09-06
SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S001)Globus Medical, Inc.2013-03-15