FDA.reportPublic FDA data

Citrelock ACL Tibial Drill Guide, Flat Hook

Primary DI
00810027271594
Brand
Citrelock ACL Tibial Drill Guide, Flat Hook
Company
Acuitive Technologies, Inc.
Model
40-103-0016
Catalog number
40-103-0016
Published
2024-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXYBrace, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXYBrace, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810027271594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810027271594008100272715948100272715940810027271594

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
074645634
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
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
00810027271105Citrelock ACL Inserter40-103-000340-103-00032023-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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05055662971293Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971309Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971316Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971323Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
00889024682399PSN TM TIB DRILL GDEZimmer, Inc.HXY2025-01-13
00191083044569Meniscus Allograft Transplantation (MAT)Rti Surgical, Inc.HXY2024-10-14
04049197096812RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-16
04049197096744RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-15
04026575534678LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04026575534739LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04049197187848RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-06-28
00840183516031BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
00840183516048BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
M73910290060TransFasten-LSF, Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290130TransFasten - LSF, Sharp Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290140TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290150TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 457mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290170TransFasten - LSF, Open-Ended Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290180TransFasten - LSF, Parallel GuideCAPTIVA SPINE, INC.HXY2024-04-25
05055662969825COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969832COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969849COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969856COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969863COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969870COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
M7392030002104-Hole Drill GuideCAPTIVA SPINE, INC.HXY2024-03-11
08033860019105BIOPSYBELLBIOPSYBELL SRLHXY2024-02-23
08033860019112BIOPSYBELLBIOPSYBELL SRLHXY2024-02-23