FDA.reportPublic FDA data

Sterile Posterior Spinal Fixation System

Primary DI
06941312465795
Brand
Sterile Posterior Spinal Fixation System
Company
Shanghai Reach Medical Instrument Co., Ltd
Model
SB21D-26555
Published
2026-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221745000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221745000Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.2022-08-31NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941312465795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941312465795069413124657956941312465795

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Regulatory Flags#

DUNS number
530695344
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941312465559Sterile Posterior Spinal Fixation SystemSB211-350702026-05-22
06941312465566Sterile Posterior Spinal Fixation SystemSB211-350752026-05-22
06941312465573Sterile Posterior Spinal Fixation SystemSB211-350802026-05-22
06941312465580Sterile Posterior Spinal Fixation SystemSB211-350852026-05-22
06941312465597Sterile Posterior Spinal Fixation SystemSB211-350902026-05-22
06941312465603Sterile Posterior Spinal Fixation SystemSB211-350952026-05-22
06941312465610Sterile Posterior Spinal Fixation SystemSB211-351002026-05-22
06941312465627Sterile Posterior Spinal Fixation SystemSB211-351052026-05-22
06941312465634Sterile Posterior Spinal Fixation SystemSB211-351102026-05-22
06941312465641Sterile Posterior Spinal Fixation SystemSB211-351152026-05-22
06941312465658Sterile Posterior Spinal Fixation SystemSB211-351202026-05-22
06941312465665Sterile Posterior Spinal Fixation SystemSB211-351252026-05-22
06941312465672Sterile Posterior Spinal Fixation SystemSB211-351302026-05-22
06941312465689Sterile Posterior Spinal Fixation SystemSB211-351352026-05-22
06941312465696Sterile Posterior Spinal Fixation SystemSB211-351402026-05-22
06941312465702Sterile Posterior Spinal Fixation SystemSB211-351452026-05-22
06941312465733Sterile Posterior Spinal Fixation SystemSB21D-255452026-05-22
06941312465740Sterile Posterior Spinal Fixation SystemSB21D-255502026-05-22
06941312465757Sterile Posterior Spinal Fixation SystemSB21D-265352026-05-24
06941312465764Sterile Posterior Spinal Fixation SystemSB21D-265402026-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008401853825664CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825734CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825804CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
008401853825974CIS WILL PEDICLE SCREW SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDNKB2026-05-25
07290014381254ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290014381261ProMIS™ Fixation SystemPREMIA SPINE LTDNKB2026-05-25
07290115935615Counter Torque STPREMIA SPINE LTDNKB2026-05-25
06941312465757Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465764Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465771Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465788Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465801Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465818Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465825Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465832Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465849Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465856Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465887Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465894Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465900Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-24
06941312465559Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465566Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465573Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465580Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465597Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465603Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465610Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465627Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465634Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22
06941312465641Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co., LtdNKB2026-05-22