FDA.reportPublic FDA data

CitreLock 5.0mm Reamer

Primary DI
00810027270047
Brand
CitreLock 5.0mm Reamer
Company
Acuitive Technologies, Inc.
Model
40-101-1050
Catalog number
40-101-1050
Published
2020-11-24
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
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200725000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200725000Citregen Tendon Interference Screw and CitrelockAcuitive Technologies2020-10-07MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810027270047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810027270047008100272700478100272700470810027270047

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
201-661-2680xxx@xx.xx

Regulatory Flags#

DUNS number
074645634
Device count
1
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
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
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
00810112598537DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598544DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598551DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598568DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598575DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598599DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598605DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598612DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598629DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598636DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112592269TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592276TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592283TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592290TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592306TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592313TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592320TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592337TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592344TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592351TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592368TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592375TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592382TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00810112592399TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTO2024-02-23
00850310006434CrossTIE™ Reamer 2.2mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006441CrossTIE™ Reamer 2.5mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006458CrossTIE™ Reamer 2.7mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00850310006465CrossTIE™ Reamer 3.0mmCROSSROADS EXTREMITY SYSTEMSHTO2023-01-05
00815432028641MotoBAND CP Reamer, 2.0mmCROSSROADS EXTREMITY SYSTEMSHTO2022-11-30