QUANTUM™* SPINAL FIXATION SYSTEM 10-LHO-R
GUDID 00846468020897
LAMINAR HOOK, OFFSET RIGHT
Pioneer Surgical Technology, Inc.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00846468020897 |
| NIH Device Record Key | d2bbe65c-4c9c-4f85-a1c1-3c87e9d6325e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUANTUM™* SPINAL FIXATION SYSTEM |
| Version Model Number | 10-LHO-R |
| Catalog Number | 10-LHO-R |
| Company DUNS | 793384496 |
| Company Name | Pioneer Surgical Technology, 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 |
Customer Support Contacts
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468020897 [Primary] |
| GS1 | 00846468090203 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101790
FDA Product Code
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
[00846468020897]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-11-23 |
On-Brand Devices [QUANTUM™* SPINAL FIXATION SYSTEM]
| 00846468050559 | ROD, HEX END |
| 00846468022211 | THORACIC LAMINAR HOOK, SMALL |
| 00846468022204 | THORACIC LAMINAR HOOK, LARGE |
| 00846468022198 | THORACIC LAMINAR HOOK, ANGLED, RIGHT |
| 00846468022174 | THORACIC LAMINAR HOOK, ANGLED, LEFT |
| 00846468021603 | ROD CONNECTOR, PARALLEL, MULTI |
| 00846468021597 | ROD CONNECTOR, PARALLEL |
| 00846468021580 | ROD CONNECTOR, END TO END, MULTI |
| 00846468021573 | ROD CONNECTOR, END TO END |
| 00846468021528 | PRE CONTOURED, J-ROD, RIGHT |
| 00846468021511 | PRE CONTOURED, J-ROD, LEFT |
| 00846468021504 | PRE CONTOURED, J-ROD, RIGHT |
| 00846468021498 | PRE CONTOURED, J-ROD, LEFT |
| 00846468021481 | PRE CONTOURED, J-ROD, RIGHT |
| 00846468021474 | PRE CONTOURED, J-ROD, LEFT |
| 00846468021467 | PRE CONTOURED, J-ROD, RIGHT |
| 00846468021450 | PRE CONTOURED, J-ROD, LEFT |
| 00846468021443 | PRE CONTOURED, J-ROD, RIGHT |
| 00846468021436 | PRE CONTOURED, J-ROD, LEFT |
| 00846468021429 | PRE CONTOURED, J-ROD, RIGHT |
| 00846468021412 | PRE CONTOURED, J-ROD, LEFT |
| 00846468021405 | PRE CONTOURED, J-ROD, RIGHT |
| 00846468021399 | PRE CONTOURED, J-ROD, LEFT |
| 00846468021320 | PEDICLE HOOK, SMALL |
| 00846468021313 | PEDICLE HOOK, MEDIUM |
| 00846468021306 | PEDICLE HOOK, LARGE |
| 00846468020989 | LATERAL OFFSET CONNECTOR |
| 00846468020972 | LATERAL OFFSET CONNECTOR |
| 00846468020965 | LATERAL OFFSET CONNECTOR |
| 00846468020958 | LAMINAR HOOK, LUMBAR, SMALL |
| 00846468020934 | LAMINAR HOOK, LUMBAR, LARGE |
| 00846468020927 | LAMINAR HOOK EXTENDED, LUMBAR, SMALL |
| 00846468020903 | LAMINAR HOOK EXTENDED, LUMBAR, LARGE |
| 00846468020897 | LAMINAR HOOK, OFFSET RIGHT |
| 00846468020880 | LAMINAR HOOK, OFFSET LEFT |
| 00846468020866 | LOCKING CAP |
| 00846468020309 | PEDICLE SCREW, FIXED |
| 00846468020293 | PEDICLE SCREW, FIXED |
| 00846468020286 | PEDICLE SCREW, FIXED |
| 00846468020279 | PEDICLE SCREW, FIXED |
| 00846468020262 | PEDICLE SCREW, FIXED |
| 00846468020255 | PEDICLE SCREW, FIXED |
| 00846468020248 | PEDICLE SCREW, FIXED |
| 00846468020231 | PEDICLE SCREW, FIXED |
| 00846468020224 | PEDICLE SCREW, FIXED |
| 00846468020217 | PEDICLE SCREW, FIXED |
| 00846468020200 | PEDICLE SCREW, FIXED |
| 00846468020194 | PEDICLE SCREW, FIXED |
| 00846468020187 | PEDICLE SCREW, FIXED |
| 00846468020170 | PEDICLE SCREW, FIXED |
Trademark Results [QUANTUM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTUM 98867628 not registered Live/Pending |
Xplorian LLC 2024-11-22 |
 QUANTUM 98807712 not registered Live/Pending |
Into-Me-Sea LLC 2024-10-17 |
 QUANTUM 98804816 not registered Live/Pending |
QuantumADR LLC 2024-10-16 |
 QUANTUM 98719255 not registered Live/Pending |
Evolve Biologix Inc. 2024-08-27 |
 QUANTUM 98705080 not registered Live/Pending |
Intervet Inc. 2024-08-19 |
 QUANTUM 98650676 not registered Live/Pending |
Raynor Marketing Ltd. 2024-07-16 |
 QUANTUM 98424129 not registered Live/Pending |
HOUSE X AMERICA LLC 2024-02-27 |
 QUANTUM 98417725 not registered Live/Pending |
Meta Materials Inc. 2024-02-23 |
 QUANTUM 98388177 not registered Live/Pending |
Thomas P. Dakich 2024-02-02 |
 QUANTUM 98386723 not registered Live/Pending |
Kuku, Jalil 2024-02-01 |
 QUANTUM 98384415 not registered Live/Pending |
Starkey Laboratories, Inc. 2024-01-31 |
 QUANTUM 98362353 not registered Live/Pending |
The Upper Deck Company 2024-01-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.