FDA.reportPublic FDA data

SAS PI-Rod

Primary DI
00850075160525
Brand
SAS PI-Rod
Company
SPINAL ALIGNMENT SOLUTIONS, INC.
Model
1
Catalog number
FGN-405055TI-0
Device description
PI-ROD CADDY BASE - PI RANGE 40-50
Published
2026-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850075160525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850075160525008500751605258500751605250850075160525

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
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
00850075160112SAS PI-Rod1PI004055TIL4S12026-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630008405793APTUSMedartis AGFSM2026-07-16
07630008405809APTUSMedartis AGFSM2026-07-16
07630008405878APTUSMedartis AGFSM2026-07-16
07630008405892APTUSMedartis AGFSM2026-07-16
07630008406226APTUSMedartis AGFSM2026-07-16
07630008406233APTUSMedartis AGFSM2026-07-16
07630008406240APTUSMedartis AGFSM2026-07-16
07630008406257APTUSMedartis AGFSM2026-07-16
07630008406264APTUSMedartis AGFSM2026-07-16
07630008406271APTUSMedartis AGFSM2026-07-16
07630008406288APTUSMedartis AGFSM2026-07-16
07630008406295APTUSMedartis AGFSM2026-07-16
07630008406301APTUSMedartis AGFSM2026-07-16
07630008406318APTUSMedartis AGFSM2026-07-16
07630008406325APTUSMedartis AGFSM2026-07-16
07630008406332APTUSMedartis AGFSM2026-07-16
07630008428327APTUSMedartis AGFSM2026-07-16
07630008428334APTUSMedartis AGFSM2026-07-16
07630008453206APTUSMedartis AGFSM2026-07-16
07630008488284APTUSMedartis AGFSM2026-07-16
07630008488314APTUSMedartis AGFSM2026-07-16
07630008488406APTUSMedartis AGFSM2026-07-16
07630037833475APTUSMedartis AGFSM2026-07-16
07630037833482APTUSMedartis AGFSM2026-07-16
07630037846437APTUSMedartis AGFSM2026-07-16
07630037846444APTUSMedartis AGFSM2026-07-16
07630037846697APTUSMedartis AGFSM2026-07-16
07630037846802APTUSMedartis AGFSM2026-07-16
07630037847229APTUSMedartis AGFSM2026-07-16
07630037847236APTUSMedartis AGFSM2026-07-16