FDA.reportPublic FDA data

Sterile Posterior Spinal Fixation System

Primary DI
06941312466020
Brand
Sterile Posterior Spinal Fixation System
Company
Shanghai Reach Medical Instrument Co., Ltd
Model
SB211-32110
Published
2026-05-31
Public version status
New
Distribution status
Not 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
06941312466020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941312466020069413124660206941312466020

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
06941312465719Sterile Posterior Spinal Fixation SystemSB211-351502026-05-31
06941312466013Sterile Posterior Spinal Fixation SystemSB211-321052026-05-31
06941312466037Sterile Posterior Spinal Fixation SystemSB211-321202026-05-31
06941312466044Sterile Posterior Spinal Fixation SystemSB211-321302026-05-31
06941312466051Sterile Posterior Spinal Fixation SystemSB211-321402026-05-31
06941312466068Sterile Posterior Spinal Fixation SystemSB211-321502026-05-31
06941312466075Sterile Posterior Spinal Fixation SystemSB211-322002026-05-31
06941312466082Sterile Posterior Spinal Fixation SystemSB211-323002026-05-31
06941312466099Sterile Posterior Spinal Fixation SystemSB217-303402026-05-31
06941312466105Sterile Posterior Spinal Fixation SystemSB217-303502026-05-31
06941312466112Sterile Posterior Spinal Fixation SystemSB217-303602026-05-31
06941312466129Sterile Posterior Spinal Fixation SystemSB217-303702026-05-31
06941312466136Sterile Posterior Spinal Fixation SystemSB217-303802026-05-31
06941312466143Sterile Posterior Spinal Fixation SystemSB216-010952026-05-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935578PER Trial 60PREMIA SPINE LTDNKB2026-07-22
07290115935691PER Trial 50PREMIA SPINE LTDNKB2026-07-22
00840466901035PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.NKB2026-07-21