FDA.reportPublic FDA data

Sterile Posterior Spinal Fixation System

Primary DI
06941312466075
Brand
Sterile Posterior Spinal Fixation System
Company
Shanghai Reach Medical Instrument Co., Ltd
Model
SB211-32200
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
06941312466075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941312466075069413124660756941312466075

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
06941312466020Sterile Posterior Spinal Fixation SystemSB211-321102026-05-31
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
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
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00197157118389ZAVATION SCREWZavation LLCNKB2026-10-01
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00197157118570ZAVATION SCREWZavation LLCNKB2026-10-01