FDA.reportPublic FDA data

3.5 X 15.5mm Citrefix XPress System

Primary DI
00810027270863
Brand
3.5 X 15.5mm Citrefix XPress System
Company
Acuitive Technologies, Inc.
Model
70-810-3515
Published
2022-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBit, Drill
HXGTamp
HXYBrace, Drill
MAIFastener, Fixation, Biodegradable, Soft Tissue
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
HXGTampOrthopedic1
HXYBrace, DrillOrthopedic1
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203334000The Citrefix Knotless Suture AnchorAcuitive Technologies, Inc.2021-02-05MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810027270863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810027270863008100272708638100272708630810027270863

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, bioabsorbableA bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-661-2680mpoggie@acuitivetech.com

Regulatory Flags#

DUNS number
074645634
Device count
1
Kit
true
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
008100272722943cc Citregraft Cylinder36-106-000436-106-00042025-10-01
008100272723006cc Citregraft Cylinder36-106-000536-106-00052025-10-01
0081002727231712.5cc Citregraft Cylinder36-106-000636-106-00062025-10-01
00810027271594Citrelock ACL Tibial Drill Guide, Flat Hook40-103-001640-103-00162024-12-03
00810027271600Citrelock ACL 6mm Femoral Drill Guide, Straight Tip40-103-006140-103-00612024-12-03
00810027271617Citrelock ACL 7mm Femoral Drill Guide, Straight Tip40-103-007140-103-00712024-12-03
00810027271624Citrelock ACL 1.5mm K-Wire40-103-001540-103-00152024-12-03
00810027270436Citrefix 2.9mm Inserter40-100-402940-100-40292023-06-24
00810027270443Citrefix 3.5mm Inserter40-100-403540-100-40352023-06-24
00810027270450Citrefix 4.5mm Inserter40-100-404540-100-40452023-06-24
00810027270467Citrefix 5.5mm Inserter40-100-405540--100-40552023-06-24
00810027270894Citrefix 2.9mm Inserter Center Shaft40-100-102940-100-10292023-06-24
00810027270900Citrefix 3.5mm Inserter Center Shaft40-100-103540-100-10352023-06-24
00810027270917Citrefix 4.5mm Inserter Center Shaft40-100-104540-100-10452023-06-24
00810027270924Citrefix 5.5mm Inserter Center Shaft40-100-105540-100-10552023-06-24
00810027271051Citrefix 2.9mm Inserter Plunger40-100-202940-100-20292023-06-24
00810027271068Citrefix 3.5mm Inserter Plunger40-100-203540-100-20352023-06-24
00810027271075Citrefix 4.5mm Inserter Plunger40-100-204540-100-20452023-06-24
00810027271082Citrefix 5.5mm Inserter Plunger40-100-205540-100-20552023-06-24
00810027271099Citrefix Center Shaft Retaining Clamp40-100-001040-100-00102023-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816537023012FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023029FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023036FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023043FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023050FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023067FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023234FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00860013918606ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918613ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918620ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918637ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
04052536176700neon3Ulrich GmbH & Co. KGHTW2026-06-08
04052536176717neon3Ulrich GmbH & Co. KGHTW2026-06-08
00199150076178Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXG2026-06-05
00196449017355A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
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00196449017416A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017423A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
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00196449017447A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
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00196449017485A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
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00196449017522A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017539A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017546A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04