FDA.reportPublic FDA data

Specials

Primary DI
10889981442101
Brand
Specials
Company
Seaspine Orthopedics Corporation
Model
SR-1450
Catalog number
SR-1450
Device description
Stab and Grab Poly Driver
Published
2026-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKGPosterior cervical screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193615000NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation2020-03-25NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981442101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998144210110889981442101

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079840876
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981442187REEF LRL2-100608RL2-1006082026-06-19
10889981443344REEF LRL3-109002RL3-1090022026-06-19
10889981326234RegattaRP1-200200RP1-2002002025-01-17
10889981326777RegattaRP1-000308RP1-0003082025-01-17
10889981326784RegattaRP1-000310RP1-0003102025-01-17
10889981326791RegattaRP1-000312RP1-0003122025-01-17
10889981326807RegattaRP1-000314RP1-0003142025-01-17
10889981326814RegattaRP1-000316RP1-0003162025-01-17
10889981326821RegattaRP1-000318RP1-0003182025-01-17
10889981326838RegattaRP1-000320RP1-0003202025-01-17
10889981329969RegattaRP3-209300RP3-2093002025-01-17
10889981330002WaveForm LWL4-184015WL4-1840152025-01-17
10889981330026WaveForm LWL4-184515WL4-1845152025-01-17
10889981330040WaveForm LWL4-185015WL4-1850152025-01-17
10889981330064WaveForm LWL4-185515WL4-1855152025-01-17
10889981330088WaveForm LWL4-186015WL4-1860152025-01-17
10889981330101WaveForm LWL4-284015WL4-2840152025-01-17
10889981330125WaveForm LWL4-284515WL4-2845152025-01-17
10889981330149WaveForm LWL4-285015WL4-2850152025-01-17
10889981330163WaveForm LWL4-285515WL4-2855152025-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901011PrimusSPINAL ELEMENTS, INC.KWP2026-10-22
00840019978156Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978163Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978170Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978187Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978194Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978200Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978217Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978224Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978231Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978248Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978255Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978262Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978279Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978286Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978293Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978309Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978316Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978323Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978330Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978347Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978354Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978361Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978378Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978385Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978392Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978408Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978415Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978422Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978439Reform TiPRECISION SPINE, INC.KWP2026-10-19