FDA.reportPublic FDA data

NA

Primary DI
04250869604307
Brand
NA
Company
Biedermann Motech GmbH & Co. KG
Model
107-022-0095
Catalog number
107-022-0095
Device description
MOSS Ti Rod, Ø5.5x95mm, straight
Published
2018-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K162232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162232000MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG2016-11-17NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250869604307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250869604307042508696043074250869604307

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-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. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
320249162
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04255772613071NA207-060-0138207-060-01382025-08-08
04255772613088NA207-060-0137207-060-01372025-08-08
04250869654180NA108-004-0004108-004-00042020-08-14
04250869602907NA107-004-0001107-004-00012017-01-10
04250869607469NA109-015-0828109-015-08282017-06-20
04250869607629NA109-031-0728109-031-07282017-06-20
04250869607636NA109-015-0928109-015-09282017-06-20
04250869607643NA109-015-1028109-015-10282017-06-20
04250869607650NA109-015-1128109-015-11282017-06-20
04250869607667NA109-015-1228109-015-12282017-06-20
04250869607674NA109-015-1328109-015-13282017-06-20
04250869607681NA109-031-0732109-031-07322017-06-20
04250869607698NA109-015-0832109-015-08322017-06-20
04250869607704NA109-015-0932109-015-09322017-06-20
04250869607711NA109-015-1032109-015-10322017-06-20
04250869607728NA109-015-1132109-015-11322017-06-20
04250869607735NA109-015-1232109-015-12322017-06-20
04250869607742NA109-015-1332109-015-13322017-06-20
04250869607759NA109-015-1432109-015-14322017-06-20
04250869607766NA109-015-1532109-015-15322017-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
10888857598164Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598256Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598263Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598270Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598287Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598409Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24