FDA.reportPublic FDA data

Paeon Posterior Cervical Fixation System

Primary DI
00840273318200
Brand
Paeon Posterior Cervical Fixation System
Company
Aegis Spine, Inc.
Model
6142-2248S
Catalog number
6142-2248S
Device description
Cervical Right Side Rod to Rod Connector Ø4.6x11.3x15.0mm, 20°
Published
2022-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221050000ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate SystemAegis Spine, Inc.2022-06-30OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840273318200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840273318200008402733182008402733182000840273318200

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017993061
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840273312246ZESPIN SI Joint Fusion SystemSI01-0502SI01-05022022-05-06
00840273320937Paeon Anterior Cervical Plate System6712-17316712-17312023-01-30
00840273320944Paeon Anterior Cervical Plate System6712-17336712-17332023-01-30
00840273320951Paeon Anterior Cervical Plate System6713-17426713-17422023-01-30
00840273320968Paeon Anterior Cervical Plate System6713-17456713-17452023-01-30
00840273320975Elatus Lumbar Plate System5015-14265015-14262023-01-30
00840273320982Elatus Lumbar Plate System5015-15275015-15272023-01-30
00840273320999Elatus Lumbar Plate System5015-16285015-16282023-01-30
00840273321002Elatus Lumbar Plate System5015-18305015-18302023-01-30
00840273321286Paeon Anterior Cervical Plate System6712-1731S6712-1731S2023-01-30
00840273321293Paeon Anterior Cervical Plate System6712-1733S6712-1733S2023-01-30
00840273321309Paeon Anterior Cervical Plate System6713-1742S6713-1742S2023-01-30
00840273321316Paeon Anterior Cervical Plate System6713-1745S6713-1745S2023-01-30
00840273321323Elatus Lumbar Plate System5015-1426S5015-1426S2023-01-30
00840273321330Elatus Lumbar Plate System5015-1527S5015-1527S2023-01-30
00840273321347Elatus Lumbar Plate System5015-1628S5015-1628S2023-01-30
00840273321354Elatus Lumbar Plate System5015-1830S5015-1830S2023-01-30
00840273310976Paeon Posterior Cervical Fixation SystemCS02-0702CS02-07022022-05-03
00840273311003Paeon Posterior Cervical Fixation SystemCS02-0705CS02-07052022-05-03
00840273311010Paeon Posterior Cervical Fixation SystemCS02-0706CS02-07062022-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536085491neon3Ulrich GmbH & Co. KGNKG2026-05-28
07630345705860M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705877M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705884M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705891M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705907M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705914M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705921M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705938M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705945M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705952M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630971299559M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299566M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299573M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299580M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299597M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299528M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299535M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299542M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299368M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299375M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299382M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299399M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299405M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299412M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299429M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299436M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299443M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299450M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299467M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19