DELTA XTEND 230770016
GUDID 10603295116066
DELTA Xtend HANDLE FOR CUTTING GUIDE DIA 16 MM
DEPUY (IRELAND)
Orthopaedic prosthesis implantation instrument, reusable| Primary Device ID | 10603295116066 |
| NIH Device Record Key | fb9e3e06-5b75-433a-bda9-6046ef462b26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DELTA XTEND |
| Version Model Number | 2307-70-016 |
| Catalog Number | 230770016 |
| Company DUNS | 989365556 |
| Company Name | DEPUY (IRELAND) |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295116066 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170748
FDA Product Code
| HTZ | INSTRUMENT, CUTTING, ORTHOPEDIC |
| PHX | shoulder prosthesis, reverse configuration |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10603295116066]
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[10603295116066]
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[10603295116066]
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[10603295116066]
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[10603295116066]
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[10603295116066]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-07-23 |
| Device Publish Date | 2018-06-19 |
On-Brand Devices [DELTA XTEND]
| 10603295507147 | DELTA XTEND 145 Degree EPI / LATERALIZED LID |
| 10603295507130 | DELTA XTEND 145 Degree EPI / LATERALIZED CASE |
| 10603295507345 | DELTA XTEND Lateralized Glenosphere +8mm Trial Standard diameter 42mm |
| 10603295507338 | DELTA XTEND Lateralized Glenosphere +6mm Trial Standard diameter 42mm |
| 10603295507321 | DELTA XTEND Lateralized Glenosphere +4mm Trial Standard diameter 42mm |
| 10603295507314 | DELTA XTEND Lateralized Glenosphere +2mm Trial Standard diameter 42mm |
| 10603295507307 | DELTA XTEND Lateralized Glenosphere +0mm Trial Standard diameter 42mm |
| 10603295507291 | DELTA XTEND Lateralized Glenosphere +8mm Trial Standard diameter 38mm |
| 10603295507284 | DELTA XTEND Lateralized Glenosphere +6mm Trial Standard diameter 38mm |
| 10603295507277 | DELTA XTEND Lateralized Glenosphere +2mm Trial Eccentric diameter 38mm |
| 10603295507260 | DELTA XTEND Lateralized Glenosphere +0mm Trial Eccentric diameter 38mm |
| 10603295507253 | DELTA XTEND Lateralized Glenosphere +4mm Trial Standard diameter 38mm |
| 10603295507246 | DELTA XTEND Lateralized Glenosphere +2mm Trial Standard diameter 38mm |
| 10603295507239 | DELTA XTEND Lateralized Glenosphere +0mm Trial Standard diameter 38mm |
| 10603295507222 | DELTA XTEND Lateralized Glenosphere +8mm Trial Eccentric diameter 42mm |
| 10603295507215 | DELTA XTEND Lateralized Glenosphere +6mm Trial Eccentric diameter 42mm |
| 10603295507208 | DELTA XTEND Lateralized Glenosphere +4mm Trial Eccentric diameter 42mm |
| 10603295507192 | DELTA XTEND Lateralized Glenosphere +2mm Trial Eccentric diameter 42mm |
| 10603295507185 | DELTA XTEND Lateralized Glenosphere +0mm Trial Eccentric diameter 42mm |
| 10603295507178 | DELTA XTEND Lateralized Glenosphere +8mm Trial Eccentric diameter 38mm |
| 10603295507161 | DELTA XTEND Lateralized Glenosphere +6mm Trial Eccentric diameter 38mm |
| 10603295507154 | DELTA XTEND Lateralized Glenosphere +4mm Trial Eccentric diameter 38mm |
| 10603295502647 | DELTA XTEND Lateralized Glenosphere +6mm Eccentric 042mm |
| 10603295502630 | DELTA XTEND Lateralized Glenosphere +6mm Eccentric 038mm |
| 10603295502623 | DELTA XTEND Lateralized Glenosphere +6mm Standard 042mm |
| 10603295502616 | DELTA XTEND Lateralized Glenosphere +6mm Standard 038mm |
| 10603295502609 | DELTA XTEND Lateralized Glenosphere +0mm Eccentric 042mm |
| 10603295502593 | DELTA XTEND Lateralized Glenosphere +0mm Eccentric 038mm |
| 10603295502562 | DELTA XTEND Lateralized Glenosphere +0mm Standard 042mm |
| 10603295502555 | DELTA XTEND Lateralized Glenosphere +0mm Standard 038mm |
| 10603295502548 | DELTA XTEND Lateralized Glenosphere +8mm Standard 042mm |
| 10603295502531 | DELTA XTEND Lateralized Glenosphere +8mm Standard 038mm |
| 10603295502524 | DELTA XTEND Lateralized Glenosphere +8mm Eccentric 042mm |
| 10603295502517 | DELTA XTEND Lateralized Glenosphere +8mm Eccentric 038mm |
| 10603295502500 | DELTA XTEND Lateralized Glenosphere +2mm Standard 042mm |
| 10603295502494 | DELTA XTEND Lateralized Glenosphere +2mm Standard 038mm |
| 10603295502487 | DELTA XTEND Lateralized Glenosphere +4mm Eccentric 042mm |
| 10603295502470 | DELTA XTEND Lateralized Glenosphere +4mm Eccentric 038mm |
| 10603295502463 | DELTA XTEND Lateralized Glenosphere +4mm Standard 042mm |
| 10603295502456 | DELTA XTEND Lateralized Glenosphere +4mm Standard 038mm |
| 10603295502449 | DELTA XTEND Lateralized Glenosphere +2mm Eccentric 042mm |
| 10603295502432 | DELTA XTEND Lateralized Glenosphere +2mm Eccentric 038mm |
| 10603295423652 | DELTA XTEND Cementless Metaglene +15mm HA |
| 10603295423645 | DELTA XTEND Cementless Metaglene +10mm HA |
| 10603295518853 | DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL RIGHT Size 2 |
| 10603295518846 | DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL LEFT Size 2 |
| 10603295518839 | DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL RIGHT Size 1 |
| 10603295518822 | DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL LEFT Size 1 |
| 10603295518815 | DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL CENTERED Size 2 |
| 10603295518808 | DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL CENTERED Size 1 |
Trademark Results [DELTA XTEND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DELTA XTEND 88923776 not registered Live/Pending |
Depuy Synthes, Inc. 2020-05-19 |
 DELTA XTEND 78770907 not registered Dead/Abandoned |
DePuy, Inc. 2005-12-11 |
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