DEVICE: 4.5 X 24mm Citrefix XPress System (00810027270870)
Device Identifier (DI) Information
4.5 X 24mm Citrefix XPress System
70-810-4524
In Commercial Distribution
Acuitive Technologies, Inc.
70-810-4524
In Commercial Distribution
Acuitive Technologies, Inc.
No description.
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45061 | Tendon/ligament bone anchor, bioabsorbable |
A 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).
|
Active | true |
57789 | Surgical drill guide, single-use |
A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It 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 at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.
|
Active | false |
43390 | Fluted surgical drill bit, single-use |
A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.
|
Active | false |
64237 | Orthopaedic inorganic implant inserter/extractor, single-use |
A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAI | Fastener, Fixation, Biodegradable, Soft Tissue |
MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
HXG | Tamp |
HTW | Bit, Drill |
HXY | Brace, Drill |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K203334 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
d165347c-28fb-4a57-b06a-aaecfe31833c
September 11, 2024
2
July 15, 2022
September 11, 2024
2
July 15, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
201-661-2680
mpoggie@acuitivetech.com
mpoggie@acuitivetech.com