FDA.reportPublic FDA data

Pro-Link Barb

Primary DI
00190837200701
Brand
Pro-Link Barb
Company
Life Spine, Inc.
Model
129-259
Published
2026-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231704000Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.2023-10-19OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190837200701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190837200701001908372007011908372007010190837200701

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
183641617
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190837124137Arx17-8575-032026-04-17
00190837124144Arx17-8580-032026-04-17
00190837124151Arx17-8585-032026-04-17
00190837124168Arx17-8590-032026-04-17
00190837124175Arx17-8595-032026-04-17
00190837124243Arx17-9525-032026-04-17
00190837124250Arx17-9530-032026-04-17
00190837124267Arx17-9535-032026-04-17
00190837124274Arx17-9540-032026-04-17
00190837124281Arx17-9545-032026-04-17
00190837124298Arx17-9550-032026-04-17
00190837124304Arx17-9555-032026-04-17
00190837124311Arx17-9560-032026-04-17
00190837124397Arx17-95100-032026-04-17
00190837124403Arx17-95105-032026-04-17
00190837124410Arx17-95110-032026-04-17
00190837124427Arx17-95115-032026-04-17
00190837124434Arx17-95120-032026-04-17
00190837125912Arx17-8575-132026-04-17
00190837125929Arx17-8580-132026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719G45170Stasys-C StandaloneGenesys Orthopedics Systems LLCOVE2026-08-03
M719G45180Stasys-C StandaloneGenesys Orthopedics Systems LLCOVE2026-08-03
B064XMPHC1640202Ø4.0mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1640222Ø4.0mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1640242Ø4.0mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1645202Ø4.5mm X 20mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1645222Ø4.5mm X 22mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
B064XMPHC1645242Ø4.5mm X 24mm VARIABLE ANGLE MULTILEVEL PLATE SCREWSXENCO MEDICAL LLCOVE2026-07-28
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.OVE2026-07-23
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