FDA.reportPublic FDA data

STERN FIX

Primary DI
28437006085452
Brand
STERN FIX
Company
NEOS SURGERY SL
Model
SC010222
Device description
STERN FIX Sternal Stabilization System, Size 2
Published
2024-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDQCerclage, Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221795000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221795000STERN FIX Sternal Stabilization SystemNeos Surgery S.L2022-10-19JDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28437006085452PackageGS164In Commercial Distribution
08437006085458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2843700608545228437006085452
08437006085458084370060854588437006085458

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+34935944726info@neosurgery.com

Regulatory Flags#

DUNS number
465890437
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
false
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
08437006085458STERN FIXSC0102222024-09-04
08437006085465STERN FIXSC0103332024-09-04
08437006085489STERN FIXSC0105552024-09-04
08437006085182Depth GaugeSCI00002024-09-04
08437006085212RetractorSCI03002024-09-04
08437006085434CutterSCI07002024-09-04
28437006085469STERN FIXSC0103332024-09-04
08437006085472STERN FIXSC0104442024-09-04
28437006085483STERN FIXSC0105552024-09-04
08437006085496ForcepsSCI05012024-09-04
08437006085441STERN FIXSC0101112024-09-01
28437006085445STERN FIXSC0101112024-09-01
08437006085076Cranial COVER “14 mm / 13 mm”FC0503002017-05-11
08437006085083Cranial COVER “10-12 mm”FC0504002017-05-11
18437006085042Cranial LOOPFC0500002015-11-08
18437006085066Cranial LOOP XLFC0502002016-02-04
48437006085043Cranial LOOPFC0500002015-11-08
18437006085059Cranial LOOP LFC0501002016-02-04
48437006085067Cranial LOOP XLFC0502002016-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982520502STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520519STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520526STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520533STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520540STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520557STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520564STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520571STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00888867525924Arthrex®ARTHREX, INC.JDQ2025-10-20
00888867525931Arthrex®ARTHREX, INC.JDQ2025-10-20
07899258607887Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
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07899258607962Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607979Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607986Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
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07899258608051Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258608068Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258608075Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16