FDA.reportPublic FDA data

PERLA ®

Primary DI
07640450866042
Brand
PERLA ®
Company
SpineArt SA
Model
CPF-OR TS AD-S
Catalog number
CPF-OR TS AD-S
Device description
KIT OF 2 ADJUSTABLE OCCIPITAL RODS TITANIUM Size S
Published
2025-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640450866042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640450866042076404508660427640450866042

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
483016148
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
07640221373359PERLA ® TLTLF-IN 36 10-NTLF-IN 36 10-N2026-02-09
07640221373366PERLA ® TLTLF-IN 36 00-NTLF-IN 36 00-N2026-02-09
07640221373373PERLA ® TLTLF-IN 05 60-NTLF-IN 05 60-N2026-02-09
07640221373380PERLA ® TLTLF-IN 05 70-NTLF-IN 05 70-N2026-02-09
07640151082482ROMEO 2 MISMIS-IN 04 01-NMIS-IN 04 01-N2026-02-05
07640151082499ROMEO 2 MISMIS-IN 05 01-NMIS-IN 05 01-N2026-02-05
07640332477854PERLA ®SPE-IN 01 63-NSPE-IN 01 63-N2026-02-05
07640375236081Cure OPEL-C1100-950-001100-950-002026-02-05
07640450868879PERLA ® TL MIS NAVNAV-BX 30 20-NNAV-BX 30 20-N2026-02-05
07640450866479BAGUERA CLID-BX 04 00-NLID-BX 04 00-N2026-01-30
07640332471548PERLA ® TLTLF-IN 23 60-NTLF-IN 23 60-N2026-01-05
07640185349650PERLA ® TLTLF-IN 13 30-NTLF-IN 13 30-N2025-11-20
07640270064178CURE ACP7-00001-187-00001-182025-11-20
07640270064192CURE ACP7-00001-207-00001-202025-11-20
07640270064215CURE ACP7-00001-227-00001-222025-11-20
07640270064239CURE ACP7-00001-247-00001-242025-11-20
07640270064291CURE ACP7-00001-307-00001-302025-11-20
07640270064345CURE ACPS1-7-00001-20S1-7-00001-202025-11-20
07640270064475CURE ACP7-00002-307-00002-302025-11-20
07640270064499CURE ACP7-00002-327-00002-322025-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536216710neon3Ulrich GmbH & Co. KGNKG2026-05-26
07290117356876CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-03-23
17290117356880CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-03-23
17290117356897CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-03-23
00763000990695INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC MINIMED, INC.NKG2026-03-22
00763000990701INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990718INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990725INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990732INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990749INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990756INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990763INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990770INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990787INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990794INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990800INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990817INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990824INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990831INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990848INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990855INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990862INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990879INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990886INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990893INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990909INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990916INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990923INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990930INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990947INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22