FDA.reportPublic FDA data

6 x 15mm CitreLock Xpress Implant Kit

Primary DI
00810027270320
Brand
6 x 15mm CitreLock Xpress Implant Kit
Company
Acuitive Technologies, Inc.
Model
70-812-0615
Catalog number
70-812-0615
Published
2020-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone
MAIFastener, Fixation, Biodegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

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
00810027270320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810027270320008100272703208100272703200810027270320

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, single-useA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

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

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