IXOS HS-26-906-22-09
GUDID 00850005146315
smartDrive ø2.5mm STANDARD SCREW, (L)22mm, TI
HNM STUCKENBROCK, INC.
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | 00850005146315 |
| NIH Device Record Key | 6d9bcb47-aafd-4505-a060-741a5e5add65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IXOS |
| Version Model Number | HS-26-906-22-09 |
| Catalog Number | HS-26-906-22-09 |
| Company DUNS | 117068079 |
| Company Name | HNM STUCKENBROCK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | false |
| 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 |
|---|---|
| GS1 | 00850005146315 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171624
FDA Product Code
| HRS | Plate, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
[00850005146315]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-23 |
| Device Publish Date | 2019-08-15 |
On-Brand Devices [IXOS]
| 00850005146537 | IXOS P4, NARROW, PALMAR RADIUS PLATE, (L)43mm, RT, TI |
| 00850005146520 | IXOS P2, WIDE, PALMAR RADIUS PLATE, (L)52mm, LT, TI |
| 00850005146513 | IXOS P2, WIDE, PALMAR RADIUS PLATE, (L)52mm, RT, TI |
| 00850005146506 | IXOS P2, NARROW, PALMAR RADIUS PLATE, (L)43mm, LT, TI |
| 00850005146490 | IXOS P2, NARROW, PALMAR RADIUS PLATE, (L)43mm, RT, TI |
| 00850005146674 | IXOS DL4, L-PLATE, DORSAL PLATE, (L)43mm, LT, TI |
| 00850005146667 | IXOS DL4, L-PLATE, DORSAL PLATE, (L)43mm, RT, TI |
| 00850005146650 | IXOS DL4, STRAIGHT, LATERAL PLATE, (L)52mm, TI |
| 00850005146643 | IXOS D4, NARROW, DORSAL PLATE, (W)30mm, LT, TI |
| 00850005146636 | IXOS D4, NARROW, DORSAL PLATE, (W)30mm, RT, TI |
| 00850005146629 | IXOS D4, WIDE, DORSAL PLATE, (W)32mm, LT, TI |
| 00850005146612 | IXOS D4, WIDE, DORSAL PLATE, (W)32mm, RT, TI |
| 00850005146605 | IXOS P4 WAVE, NARROW, PALMAR RADIUS PLATE, (L)52mm, LT, TI |
| 00850005146599 | IXOS P4 WAVE, NARROW, PALMAR RADIUS PLATE, (L)52mm, RT, TI |
| 00850005146582 | IXOS P4 WAVE, NARROW, PALMAR RADIUS PLATE, (L)43mm, LT, TI |
| 00850005146575 | IXOS P4 WAVE, NARROW, PALMAR RADIUS PLATE, (L)43mm, RT, TI |
| 00850005146568 | IXOS P4, WIDE, PALMAR RADIUS PLATE, (L)52mm, LT, TI |
| 00850005146551 | IXOS P4, WIDE, PALMAR RADIUS PLATE, (L)52mm, RT, TI |
| 00850005146544 | IXOS P4, NARROW, PALMAR RADIUS PLATE, (L)43mm, LT, TI |
| 00850005146483 | smartDrive ø2.0mm LOCKING PIN, (L)30mm, TI |
| 00850005146476 | smartDrive ø2.0mm LOCKING PIN, (L)30mm, TI |
| 00850005146469 | smartDrive ø2.0mm LOCKING PIN, (L)28mm, TI |
| 00850005146452 | smartDrive ø2.0mm LOCKING PIN, (L)26mm, TI |
| 00850005146445 | smartDrive ø2.0mm LOCKING PIN, (L)24mm, TI |
| 00850005146438 | smartDrive ø2.0mm LOCKING PIN, (L)22mm, TI |
| 00850005146421 | smartDrive ø2.0mm LOCKING PIN, (L)20mm, TI |
| 00850005146414 | smartDrive ø2.0mm LOCKING PIN, (L)19mm, TI |
| 00850005146407 | smartDrive ø2.0mm LOCKING PIN, (L)18mm, TI |
| 00850005146391 | smartDrive ø2.0mm LOCKING PIN, (L)17mm, TI |
| 00850005146384 | smartDrive ø2.0mm LOCKING PIN, (L)16mm, TI |
| 00850005146377 | smartDrive ø2.0mm LOCKING PIN, (L)15mm, TI |
| 00850005146360 | smartDrive ø2.0mm LOCKING PIN, (L)14mm, TI |
| 00850005146353 | smartDrive ø2.5mm STANDARD SCREW, (L)30mm, TI |
| 00850005146346 | smartDrive ø2.5mm STANDARD SCREW, (L)28mm, TI |
| 00850005146339 | smartDrive ø2.5mm STANDARD SCREW, (L)26mm, TI |
| 00850005146322 | smartDrive ø2.5mm STANDARD SCREW, (L)24mm, TI |
| 00850005146315 | smartDrive ø2.5mm STANDARD SCREW, (L)22mm, TI |
| 00850005146308 | smartDrive ø2.5mm STANDARD SCREW, (L)20mm, TI |
| 00850005146292 | smartDrive ø2.5mm STANDARD SCREW, (L)19mm, TI |
| 00850005146285 | smartDrive ø2.5mm STANDARD SCREW, (L)18mm, TI |
| 00850005146278 | smartDrive ø2.5mm STANDARD SCREW, (L)17mm, TI |
| 00850005146261 | smartDrive ø2.5mm STANDARD SCREW, (L)16mm, TI |
| 00850005146254 | smartDrive ø2.5mm STANDARD SCREW, (L)15mm, TI |
| 00850005146247 | smartDrive ø2.5mm STANDARD SCREW, (L)14mm, TI |
| 00850005146230 | smartDrive ø2.5mm STANDARD SCREW, (L)13mm, TI |
| 00850005146223 | smartDrive ø2.5mm STANDARD SCREW, (L)12mm, TI |
| 00850005146216 | smartDrive ø2.5mm STANDARD SCREW, (L)11mm, TI |
| 00850005146209 | smartDrive ø2.5mm STANDARD SCREW, (L)10mm, TI |
| 00850005146193 | smartDrive ø2.5mm STANDARD SCREW, (L)9mm, TI |
| 00850005146186 | smartDrive ø2.5mm STANDARD SCREW, (L)8mm, TI |
Trademark Results [IXOS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IXOS 88690005 not registered Live/Pending |
Compound Solutions, Inc. 2019-11-12 |
 IXOS 86919880 5067528 Live/Registered |
6th Wave Innovations Corp. 2016-02-25 |
 IXOS 79206274 5466656 Live/Registered |
MALLONI S.P.A. 2016-12-19 |
 IXOS 79020504 3240029 Dead/Cancelled |
SOPHYSA 2005-12-14 |
 IXOS 75357654 2282548 Live/Registered |
VOGEL'S HOLDING B.V. 1997-09-16 |
 IXOS 74685277 1995066 Dead/Cancelled |
IXOS Software GmbH 1995-06-06 |
 IXOS 74549441 1954273 Dead/Cancelled |
iXOS Software Inc. 1994-07-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.