FDA.reportPublic FDA data

Sterile Posterior Spinal Fixation System

Primary DI
06941312492524
Brand
Sterile Posterior Spinal Fixation System
Company
Shanghai Reach Medical Instrument Co., Ltd
Model
SB21D-25045
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
06941312492524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941312492524069413124925246941312492524

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
06941312465474Sterile Posterior Spinal Fixation SystemSB211-341502026-05-28
06941312465481Sterile Posterior Spinal Fixation SystemSB211-342002026-05-28
06941312465917Sterile Posterior Spinal Fixation SystemSB211-320552026-05-28
06941312465924Sterile Posterior Spinal Fixation SystemSB211-320602026-05-28
06941312465931Sterile Posterior Spinal Fixation SystemSB211-320652026-05-28
06941312465948Sterile Posterior Spinal Fixation SystemSB211-320702026-05-28
06941312465955Sterile Posterior Spinal Fixation SystemSB211-320752026-05-28
06941312465962Sterile Posterior Spinal Fixation SystemSB211-320802026-05-28
06941312465979Sterile Posterior Spinal Fixation SystemSB211-320852026-05-28
06941312465986Sterile Posterior Spinal Fixation SystemSB211-320902026-05-28
06941312465993Sterile Posterior Spinal Fixation SystemSB211-320952026-05-28
06941312466006Sterile Posterior Spinal Fixation SystemSB211-321002026-05-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901074Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901081Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28