FDA.reportPublic FDA data

Cortera

Primary DI
00810076562650
Brand
Cortera
Company
Surgalign Spine Technologies, Inc.
Model
150100-50075
Device description
Screw, Poly, Solid, 5.0x75
Published
2023-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K221403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221403000Cortera Spinal Fixation SystemSurgalign Spine Technologies2022-08-19NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810076562650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810076562650008100765626508100765626500810076562650

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

Contacts#

Phone, Email table
PhoneEmail
+1(844)894-7752customerservice@surgalign.com

Regulatory Flags#

DUNS number
014520584
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311242689HOLO1550000072023-04-07
00850028694237HOLO1540000532023-04-07
00850028694428HOLO1540000962023-04-07
00850028694633HOLO1540004122023-04-07
00850028694015HOLO Portal1540000172022-04-28
00850028694381HOLO Portal1540000742022-04-28
00850028694404HOLO Portal1540001002022-04-28
00850028694596HOLO1540004002023-04-07
00850028694602HOLO1540004012023-04-07
00850028694619HOLO1540004022023-04-07
00850028694626HOLO1540004102023-04-07
00810076562230Cortera150100-400652023-01-06
00810076562247Cortera150100-400702023-01-06
00810076562254Cortera150100-400752023-01-06
00810076562261Cortera150100-400802023-01-06
00810076562278Cortera150100-400852023-01-06
00810076562285Cortera150100-400902023-01-06
00810076562292Cortera150100-400952023-01-06
00810076562308Cortera150100-401002023-01-06
00810076562315Cortera150100-401052023-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157118280ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118297ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118303ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118310ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118327ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118334ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118341ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118358ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118365ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118372ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118389ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118396ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118402ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118419ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118426ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118433ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118440ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118457ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118464ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118471ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118488ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118495ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118501ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118518ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118525ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118532ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118549ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118556ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118563ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118570ZAVATION SCREWZavation LLCNKB2026-10-01