Sterile Posterior Spinal Fixation System

Primary DI
06941312465672
Brand
Sterile Posterior Spinal Fixation System
Company
Shanghai Reach Medical Instrument Co., Ltd
Model
SB211-35130
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

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
06941312465672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941312465672069413124656726941312465672

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.

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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613153045670XIA IStryker CorporationNKB2014-12-08
07613153045717XIA IStryker CorporationNKB2014-12-08
07613153045724XIA IStryker CorporationNKB2014-12-08
07613153045748XIA IStryker CorporationNKB2014-12-08
07613153045755XIA IStryker CorporationNKB2014-12-08
07613153045762XIA IIStryker CorporationNKB2014-12-08
07613153045847XIA IIStryker CorporationNKB2014-12-08
07613153045854XIA IIStryker CorporationNKB2014-12-08
07613153045861XIA IIStryker CorporationNKB2014-12-08
07613153045885XIA IIStryker CorporationNKB2014-12-08
07613153045892XIA IIStryker CorporationNKB2014-12-08
07613153045908XIA IIStryker CorporationNKB2014-12-08
07613153045915XIA IIStryker CorporationNKB2014-12-08
07613153045922XIA IIStryker CorporationNKB2014-12-08
07613153045960XIA IIStryker CorporationNKB2014-12-08
07613153046011XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046028XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046035XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046059XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046066XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046080XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046097XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046141XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046165XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046172XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153140344XIA IIStryker CorporationNKB2014-12-08
07613153140351XIA IIStryker CorporationNKB2014-12-08
07613153140368XIA IIStryker CorporationNKB2014-12-08
07613153140382XIA IIStryker CorporationNKB2014-12-08
07613153143512XIA STAINLESS STEELStryker CorporationNKB2014-12-08