FDA.reportPublic FDA data

SAS PI-Rod

Primary DI
00850075160211
Brand
SAS PI-Rod
Company
SPINAL ALIGNMENT SOLUTIONS, INC.
Model
1
Catalog number
PI506055TIL1S1
Device description
PI RANGE 50-60 - L1S1 - 5.5DIA
Published
2026-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850075160211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850075160211008500751602118500751602110850075160211

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
107603593
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850075160495SAS PI-Rod1FGN-408055TI-02026-02-16
00850075160501SAS PI-Rod1FGN-408055TI-92026-02-16
00850075160518SAS PI-Rod1FGN-004055TI-02026-02-16
00850075160525SAS PI-Rod1FGN-405055TI-02026-02-16
00850075160532SAS PI-Rod1FGN-506055TI-02026-02-16
00850075160549SAS PI-Rod1FGN-607055TI-02026-02-16
00850075160556SAS PI-Rod1FGN-708055TI-02026-02-16
00850075160563SAS PI-Rod1FGN-800055TI-02026-02-16
00850075160570SAS PI-Rod1FGN-000055TI-32026-02-16
00850075160006SAS PI-Rod1FGN-408055TI2026-02-16
00850075160013SAS PI-Rod1FGN-004055TI2026-02-16
00850075160020SAS PI-Rod1FGN-405055TI2026-02-16
00850075160037SAS PI-Rod1FGN-506055TI2026-02-16
00850075160044SAS PI-Rod1FGN-607055TI2026-02-16
00850075160051SAS PI-Rod1FGN-708055TI2026-02-16
00850075160068SAS PI-Rod1FGN-800055TI2026-02-16
00850075160075SAS PI-Rod1PI004055TIL1S12026-02-16
00850075160082SAS PI-Rod1PI004055TIL3S12026-02-16
00850075160099SAS PI-Rod1PI004055TIL3L52026-02-16
00850075160105SAS PI-Rod1PI004055TIL3L42026-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857598164Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
04546540147257XIA IIStryker CorporationNKB2014-12-08
04546540147769XIA IIStryker CorporationNKB2014-12-08
04546540147806XIA IIStryker CorporationNKB2014-12-08
04546540147905XIA IIStryker CorporationNKB2014-12-08
04546540147912XIA IStryker CorporationNKB2014-12-08
04546540147929XIA IStryker CorporationNKB2014-12-08
04546540147936XIA IStryker CorporationNKB2014-12-08
04546540147974XIA IStryker CorporationNKB2014-12-08
04546540147981XIA IStryker CorporationNKB2014-12-08
04546540147998XIA IStryker CorporationNKB2014-12-08
04546540148001XIA IIStryker CorporationNKB2014-12-08
04546540148018XIA IIStryker CorporationNKB2014-12-08
04546540148025XIA IIStryker CorporationNKB2014-12-08
04546540148735XIA IIStryker CorporationNKB2014-12-08
04546540148742XIA IIStryker CorporationNKB2014-12-08
04546540148759XIA IIStryker CorporationNKB2014-12-08