F1x Fracture Stem System

Primary DI
00811596032562
Brand
F1x Fracture Stem System
Company
CATALYST ORTHOSCIENCE INC.
Model
1232-7552-002
Catalog number
1232-7552-002
Device description
Proximal Body Med (+5) - Right
Published
2026-08-25
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
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234105000Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.2024-04-05PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811596032562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811596032562008115960325628115960325620811596032562

GMDN Terms#

Term, Definition table
TermDefinition
Total reverse shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted with or without bone cement.

Regulatory Flags#

DUNS number
079702565
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
00811596033460CSR Shoulder System1227-5120-0011227-5120-0012026-09-22
00811596033477CSR Shoulder System1227-5120-0021227-5120-0022026-09-22
00811596033484CSR Shoulder System1227-5120-0031227-5120-0032026-09-22
00811596032524F1x Fracture Stem System1232-7551-0011232-7551-0012026-08-25
00811596032531F1x Fracture Stem System1232-7551-0021232-7551-0022026-08-25
00811596032548F1x Fracture Stem System1232-7551-0031232-7551-0032026-08-25
00811596032555F1x Fracture Stem System1232-7552-0011232-7552-0012026-08-25
00811596032579F1x Fracture Stem System1232-7552-0031232-7552-0032026-08-25
00811596032586F1x Fracture Stem System1232-50031232-50032026-08-25
00811596032593F1x Fracture Stem System1232-4005-0021232-4005-0022026-08-25
00811596032609F1x Fracture Stem System1232-4005-0031232-4005-0032026-08-25
00811596032616F1x Fracture Stem System1232-4005-0041232-4005-0042026-08-25
00811596032623F1x Fracture Stem System1232-4005-0051232-4005-0052026-08-25
00811596032630F1x Fracture Stem System1232-4005-0061232-4005-0062026-08-25
00811596032647F1x Fracture Stem System1232-4005-0071232-4005-0072026-08-25
00811596032654F1x Fracture Stem System1232-4005-0081232-4005-0082026-08-25
00811596032661F1x Fracture Stem System1232-4005-0091232-4005-0092026-08-25
00811596032678F1x Fracture Stem System1232-4005-0101232-4005-0102026-08-25
00811596032685F1x Fracture Stem System1232-4005-0111232-4005-0112026-08-25
00811596032982F1x Fracture Stem System1232-4005-0121232-4005-0122026-08-25

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Primary DI, Brand, Company table
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