Morphix XT
GUDID M9701000042550
MORPHIX Foot and Ankle, 5.5MM
Medshape, Inc.
Tendon/ligament bone anchor, non-bioabsorbable| Primary Device ID | M9701000042550 |
| NIH Device Record Key | 50769779-7b89-4f7f-a231-18fa171b69ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Morphix XT |
| Version Model Number | 1000-04-255 |
| Company DUNS | 601306413 |
| Company Name | Medshape, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M9701000042550 [Primary] |
FDA Product Code
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M9701000042550]
Ethylene Oxide
[M9701000042550]
Ethylene Oxide
[M9701000042550]
Ethylene Oxide
[M9701000042550]
Ethylene Oxide
[M9701000042550]
Ethylene Oxide
[M9701000042550]
Ethylene Oxide
[M9701000042550]
Ethylene Oxide
[M9701000042550]
Ethylene Oxide
[M9701000042550]
Ethylene Oxide
[M9701000042550]
Ethylene Oxide
[M9701000042550]
Ethylene Oxide
[M9701000042550]
Ethylene Oxide
[M9701000042550]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2025-07-29 |
| Device Publish Date | 2017-02-16 |
On-Brand Devices [Morphix XT]
| M9701000042550 | MORPHIX Foot and Ankle, 5.5MM |
| M9701000042450 | MORPHIX Foot and Ankle, 4.5MM |
| M9701000041250 | MORPHIX Foot and Ankle, 2.5MM |
| M9701000032450 | MORPHIX 4.5mm x 9mm Anchor with two USP |
| M9701000032350 | MORPHIX 3.5mm x 8mm Anchor with two USP |
| M9701000032250 | MORPHIX 2.5mm x 7mm Anchor with two USP |
Trademark Results [Morphix XT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MORPHIX XT 90080830 not registered Live/Pending |
MedShape, Inc. 2020-07-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.