FDA.reportPublic FDA data

SABER-XA Angled Self-Retaining Driver, No. 20 Hexalobe

Primary DI
00810017916085
Brand
SABER-XA Angled Self-Retaining Driver, No. 20 Hexalobe
Company
ELEVATION SPINE, INC.
Model
XA-DRV-A
Catalog number
XA-DRV-A
Device description
SABER-XA Angled Self-Retaining Driver, No. 20 Hexalobe
Published
2026-10-30
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810017916085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810017916085008100179160858100179160850810017916085

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
00810017915194ALIF, Disc Prep Bottom LevelA-BASE-PREPA-BASE-PREP2026-10-30
00810017915446Pituitary Straight, #4A-PIT-4A-PIT-42026-10-30
00810017915453Pituitary Straight, #6A-PIT-6A-PIT-62026-10-30
00810017915460Kerrison, #4A-KERR-4A-KERR-42026-10-30
00810017915477Kerrison, #6A-KERR-6A-KERR-62026-10-30
00810017916191SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°)XAB-M1618XAB-M16182026-10-27
00810017913763Saber-C Body (PT), 14x15x5 6 deg.CBT-4565-PCBT-4565-P2026-10-26
00810017913770Saber-C Body (PT), 14x15x6 6 deg.CBT-4566-PCBT-4566-P2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.CBT-4567-PCBT-4567-P2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.CBT-4568-PCBT-4568-P2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.CBT-4569-PCBT-4569-P2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.CBT-4561-PCBT-4561-P2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.CBT-4595-PCBT-4595-P2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.CBT-4761-PCBT-4761-P2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.CBT-4795-PCBT-4795-P2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.CBT-4796-PCBT-4796-P2026-10-26
00810017913961Saber-C Body (PT), 14x17x7 9 deg.CBT-4797-PCBT-4797-P2026-10-26
00810017913978Saber-C Body (PT), 14x17x8 9 deg.CBT-4798-PCBT-4798-P2026-10-26
00810017913985Saber-C Body (PT), 14x17x9 9 deg.CBT-4799-PCBT-4799-P2026-10-26
00810017913992Saber-C Body (PT), 14x17x10 9 deg.CBT-4791-PCBT-4791-P2026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207596MSIModern Surgical Instruments LLCLXH2026-11-02
07630894822506APTUSMedartis AGLXH2026-11-02
07630894822551APTUSMedartis AGLXH2026-11-02
07630894822568APTUSMedartis AGLXH2026-11-02
07630894822582APTUSMedartis AGLXH2026-11-02
07630894822599APTUSMedartis AGLXH2026-11-02
07630894822629APTUSMedartis AGLXH2026-11-02
07630894822636APTUSMedartis AGLXH2026-11-02
07630894822643APTUSMedartis AGLXH2026-11-02
07630894822650APTUSMedartis AGLXH2026-11-02
07630894822681APTUSMedartis AGLXH2026-11-02
07630894823787APTUSMedartis AGLXH2026-11-02
00824846010746Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-11-01
00824846010753Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-11-01
00810017915446Pituitary Straight, #4ELEVATION SPINE, INC.LXH2026-10-30
00810017915453Pituitary Straight, #6ELEVATION SPINE, INC.LXH2026-10-30
00810017915460Kerrison, #4ELEVATION SPINE, INC.LXH2026-10-30
00810017915477Kerrison, #6ELEVATION SPINE, INC.LXH2026-10-30
00811382039348NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039355NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039362NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039379NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039386NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039393NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039409NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
00811382039416NovoKnee Total Knee SystemNovosource, LLCLXH2026-10-30
03700569680121Newclip InstrumentsNEWCLIP TECHNICSLXH2026-10-30
03700569680138Newclip InstrumentsNEWCLIP TECHNICSLXH2026-10-30
B382SD9144842000Surgical DirectSurgical Direct, Inc.LXH2026-10-30
B382SD9144842010Surgical DirectSurgical Direct, Inc.LXH2026-10-30