FDA.report

Sterile Posterior Spinal Fixation System

Primary DI
06941312465610
Brand
Sterile Posterior Spinal Fixation System
Company
Shanghai Reach Medical Instrument Co., Ltd
Model
SB211-35100
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions

SubmissionSupplement
K221745000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06941312465610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06941312465610069413124656106941312465610

GMDN Terms

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.

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 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
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
06941312465771Sterile Posterior Spinal Fixation SystemSB21D-265452026-05-24

Other Devices Sharing Product Codes

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
06941312465795Sterile 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
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