FDA.reportPublic FDA data

SABER-XA, Screw Caddy

Primary DI
00810017915309
Brand
SABER-XA, Screw Caddy
Company
ELEVATION SPINE, INC.
Model
XA-CDY-SCR
Catalog number
XA-CDY-SCR
Device description
SABER-XA, Screw Caddy
Published
2026-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810017915309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017915309008100179153098100179153090810017915309

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
085718404
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810017915293Saber-XA, Trial CaddyXA-CDY-TRIALXA-CDY-TRIAL2026-10-06
00810017915316SABER-XA, Cage & Plate Caddy, 34Wx26DXA-CDY-SXA-CDY-S2026-10-06
00810017915323SABER-XA, Cage & Plate Caddy, 37Wx28DXA-CDY-MXA-CDY-M2026-10-06
00810017915330SABER-XA, Cage & Plate Caddy, 40Wx30DXA-CDY-LXA-CDY-L2026-10-06
00810017915347SABER-XA, Spike CaddyXA-CDY-SPKXA-CDY-SPK2026-10-06
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)XAB-M1312XAB-M13122026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HXAP-M13XAP-M132026-10-01
00810017915668SABER-XA, Trial InserterXA-INS-TRIALXA-INS-TRIAL2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedXA-AWL-SXA-AWL-S2026-09-29
00810017916108SABER-XA, Expandable Spacer, 34x26mm, 11mm, (6°)XAB-S1106XAB-S11062026-09-29
00810017916115SABER-XA, Expandable Spacer, 34x26mm, 13mm, (12°)XAB-S1312XAB-S13122026-09-29
00810017916122SABER-XA, Expandable Spacer, 34x26mm, 16mm, (18°)XAB-S1618XAB-S16182026-09-29
00810017916177SABER-XA, Expandable Spacer, 37x28mm,11mm, (6°)XAB-M1106XAB-M11062026-09-29
00810017915170SABER-XA, Screw Ø5.5 x 32.5XAS-5532XAS-55302026-09-22
00810017915118Saber-C Instrument CaseCI-CADDY-TRL12CI-CADDY-TRL122026-07-27
00810017915125SABER-XA, Screw Ø5.0 x 22.5XAS-5022XAS-50222026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5XAS-5032XAS-50322026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5XAS-5522XAS-55222026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5XAS-5527XAS-55272026-09-22
00810017915132SABER-XA, Screw Ø5.0 x 27.5XAS-5027XAS-50272026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915293Saber-XA, Trial CaddyELEVATION SPINE, INC.LRP2026-10-06
00810017915316SABER-XA, Cage & Plate Caddy, 34Wx26DELEVATION SPINE, INC.LRP2026-10-06
00810017915323SABER-XA, Cage & Plate Caddy, 37Wx28DELEVATION SPINE, INC.LRP2026-10-06
00810017915330SABER-XA, Cage & Plate Caddy, 40Wx30DELEVATION SPINE, INC.LRP2026-10-06
00810017915347SABER-XA, Spike CaddyELEVATION SPINE, INC.LRP2026-10-06
10198956339156CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956552340CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956584990CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956591660CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956592162CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956603684CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956604605CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956604698CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956605756CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956605831CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956606050CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956606302CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956608917CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956498914CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956599437CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956599574CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956601581CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956370487CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956539235CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956560406CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956578586CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956585065CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956587236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956589018CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956589094CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29