FDA.reportPublic FDA data

PER System 60

Primary DI
07290115935264
Brand
PER System 60
Company
PREMIA SPINE LTD
Model
88989
Device description
PER System 60
Published
2024-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232719000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232719000ProMIS Extension Rod SystemPremia Spine, Ltd.2023-11-21NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115935264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115935264072901159352647290115935264

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius22 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649220779
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290115932508Tower Guide ST86261N2026-07-23
07290115935578PER Trial 60890602026-07-22
07290115935691PER Trial 50890972026-07-22
07290115935837MIS Tower Guide86261N2026-06-01
07290115935349TOPS 2 - 21 S889442026-07-09
07290115935356TOPS 2 - 21 M889432026-07-09
07290115935363TOPS 2 - 21 L889422026-07-09
07290115935370TOPS 2 - 30 S889472026-07-09
07290115935387TOPS 2 - 30 M889462026-07-09
07290115935394TOPS 2 - 30 L889452026-07-09
07290115935400TOPS 2 - 38 S889502026-07-09
07290115935417TOPS 2 - 38 M889492026-07-09
07290115935424TOPS 2 - 38 L889482026-07-09
07290115935783TOPS 2 Inserter888932026-07-09
07290115932492Tower ST886062026-06-01
07290115932751Alignment Gauge Medium862022026-06-01
07290115932898Cannulated Screwdriver External sleeve865132026-06-01
07290115934076Tower ST Long Window889742026-06-01
07290115935622Cannulated Screwdriver Inner Shaft Short882642026-06-01
07290115935639Cannulated Screwdriver Handle Assy Short882652026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493426426RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
M719IST80030C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80035C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18