ELEVATION SPINE

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3015991317	3015991317	ELEVATION SPINE	1	N	2026-01-01	2511 Garden Road Suite B125 Monterey CA US 93940

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
233081	2033560385	K190885	Elevation Spine Saber-C System	OVE	2019-08-07
233081	1211680508
233081	1355277486
233081	1375425672
233081	1411966003
233081	1587640904
233081	1632519645
233081	2016619537
233081	2065899835
233081	2067405268

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OVE	1	2019-08-07

PMN#

Elevation Spine Saber-C System
2019-08-07
Elevation Spine

GUDID#

Saber-C Instrument Case - CI-CADDY-TRL12
ELEVATION SPINE, INC.
2026-07-27
SABER-XA, Screw Ø5.5 x 32.5 - XAS-5532
ELEVATION SPINE, INC.
2026-09-22
SABER-XA, Screw Ø5.5 x 27.5 - XAS-5527
ELEVATION SPINE, INC.
2026-09-22
SABER-XA, Screw Ø5.5 x 22.5 - XAS-5522
ELEVATION SPINE, INC.
2026-09-22
SABER-XA, Screw Ø5.0 x 32.5 - XAS-5032
ELEVATION SPINE, INC.
2026-09-22
SABER-XA, Screw Ø5.0 x 22.5 - XAS-5022
ELEVATION SPINE, INC.
2026-09-22
SABER-XA, Screw Ø5.5 x 35 - XAS-5535
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Screw Ø5.5 x 30 - XAS-5530
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Screw Ø5.5 x 25 - XAS-5525
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Screw Ø5.5 x 20 - XAS-5520
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Screw Ø5.0 x 35 - XAS-5035
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Screw Ø5.0 x 30 - XAS-5030
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Screw Ø5.0 x 25 - XAS-5025
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Screw Ø5.0 x 20 - XAS-5020
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Straight Driver - XA-DRV-S
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Straight Drill, Guide - XA-DRILL-GDE
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Threaded Offset Handle - XA-HNDL-OF
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Axial Handle, 1/4" Sq, Ratcheting - XA-HNDL-AX
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Plate Remover - XA-RMVR-PLATE
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Screw Removal Driver - XA-RMVR-SCR
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Spike Final Driver - XA-FD-SPK
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Spike Remover - XA-RMVR-SPK
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Graft Plunger - XA-GRAFT-P
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Graft Cannula - XA-GRAFT-C
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Graft Funnel - XA-GRAFT-F
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Spike Driver, Plate - XA-DRV-SPK-P
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Inserter Knob Wrench/Driver - XA-WRENCH
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Tamp - XA-TAMP
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Spike Driver, Interbody - XA-DRV-SPK-I
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Simultaneous Expander - XA-EXP-HL
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Trial, 40x30mm, 16mm, (18°) - XA-TL1618
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Trial, 40x30mm, 13mm, (12°) - XA-TL1312
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Trial, 40x30mm, 11mm, (6°) - XA-TL1106
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Trial, 37x28mm, 16mm, (18°) - XA-TM1618
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Trial, 37x28mm, 13mm, (12°) - XA-TM1312
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Trial, 37x28mm,11mm, (6°) - XA-TM1106
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Trial, 37x28mm, 9mm, (6°) - XA-TM0906
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Trial, 34x26mm, 16mm, (18°) - XA-TS1618
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Trial, 34x26mm, 13mm, (12°) - XA-TS1312
ELEVATION SPINE, INC.
2026-09-21
SABER-XA, Trial, 34x26mm, 11mm, (6°) - XA-TS1106
ELEVATION SPINE, INC.
2026-09-21

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