Primary Device ID | 00844856035287 |
NIH Device Record Key | 78a3fc49-2552-4830-a36f-4d6857cefe48 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Novel |
Version Model Number | 64927-214 |
Company DUNS | 602465783 |
Company Name | ALPHATEC SPINE, 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 | 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 | true |
OTC Over-The-Counter | false |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com |
Width | 36 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00844856035287 [Primary] |
MQP | Spinal vertebral body replacement device |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00844856035287]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-03-10 |
Device Publish Date | 2020-03-02 |
00844856053762 | Novel Cervical Trial, 10 mm Large, 7° Lordotic |
00844856045392 | Novel Cervical Trial, 9 mm Large, 7° Lordotic |
00844856045385 | Novel Cervical Trial, 8 mm Large, 7° Lordotic |
00844856045378 | Novel Cervical Trial, 7 mm Large, 7° Lordotic |
00844856045361 | Novel Cervical Trial, 6 mm Large, 7° Lordotic |
00844856045354 | Novel Cervical Trial, 5 mm Large, 7° Lordotic |
00844856045316 | Novel Cervical Trial, 10 mm Small/Medium, 7° Lordotic |
00844856045309 | Novel Cervical Trial, 9 mm Small/Medium, 7° Lordotic |
00844856045293 | Novel Cervical Trial, 8 mm Small/Medium, 7° Lordotic |
00844856045286 | Novel Cervical Trial, 7 mm Small/Medium, 7° Lordotic |
00844856045279 | Novel Cervical Trial, 6 mm Small/Medium, 7° Lordotic |
00844856045262 | Novel Cervical Trial, 5 mm Small/Medium, 7° Lordotic |
00844856045224 | SD Cage Trial Large, 8 mm |
00844856041271 | Novel Posterior Inserter Straight Assembly |
00844856035348 | Novel Lumbar Trial, 18 mm Large, 12° Lordotic |
00844856035331 | Novel Lumbar Trial, 16 mm Large, 12° Lordotic |
00844856035324 | Novel Lumbar Trial, 14 mm Large, 12° Lordotic |
00844856035317 | Novel Lumbar Trial, 12 mm Large, 12° Lordotic |
00844856035300 | Novel Lumbar Trial, 18 mm Large, 7° Lordotic |
00844856035294 | Novel Lumbar Trial, 16 mm Large, 7° Lordotic |
00844856035287 | Novel Lumbar Trial, 14 mm Large, 7° Lordotic |
00844856035270 | Novel Lumbar Trial, 12 mm Large, 7° Lordotic |
00844856035263 | Novel Lumbar Trial, 10 mm Large, 7° Lordotic |
00844856035256 | Novel Lumbar Trial, 18 mm Medium, 12° Lordotic |
00844856035249 | Novel Lumbar Trial, 16 mm Medium, 12° Lordotic |
00844856035232 | Novel Lumbar Trial, 14 mm Medium, 12° Lordotic |
00844856035225 | Novel Lumbar Trial, 12 mm Medium, 12° Lordotic |
00844856035218 | Novel Lumbar Trial, 10 mm Medium, 12° Lordotic |
00844856035195 | Novel Lumbar Trial, 18 mm Medium, 7° Lordotic |
00844856035188 | Novel Lumbar Trial, 16 mm Medium, 7° Lordotic |
00844856035171 | Novel Lumbar Trial, 14 mm Medium, 7° Lordotic |
00844856035164 | Novel Lumbar Trial, 12 mm Medium, 7° Lordotic |
00844856035157 | Novel Lumbar Trial, 10 mm Medium, 7° Lordotic |
00844856035140 | Novel Lumbar Trial, 8 mm Medium, 7° Lordotic |
00844856035133 | Novel Lumbar Trial, 18 mm Small, 12° Lordotic |
00844856035126 | Novel Lumbar Trial, 16 mm Small, 12° Lordotic |
00844856035119 | Novel Lumbar Trial, 14 mm Small, 12° Lordotic |
00844856035102 | Novel Lumbar Trial, 12 mm Small, 12° Lordotic |
00844856035096 | Novel Lumbar Trial, 10 mm Small, 12° Lordotic |
00844856035089 | Novel Lumbar Trial, 8 mm Small, 12° Lordotic |
00844856035072 | Novel Lumbar Trial, 18 mm Small, 7° Lordotic |
00844856035065 | Novel Lumbar Trial, 16 mm Small, 7° Lordotic |
00844856035058 | Novel Lumbar Trial, 14 mm Small, 7° Lordotic |
00844856035041 | Novel Lumbar Trial, 12 mm Small, 7° Lordotic |
00844856035034 | Novel Lumbar Trial, 10 mm Small, 7° Lordotic |
00844856035027 | Novel Lumbar Trial, 8 mm Small, 7° Lordotic |
00844856034884 | Novel Lumbar Inserter Assembly |
00844856034860 | Novel Cervical Rasping Trial 12 mm, L 7° Lordotic |
00844856034846 | Novel Cervical Rasping Trial 11 mm, L 7° Lordotic |
00844856034822 | Novel Cervical Rasping Trial 10 mm, L 7° Lordotic |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NOVEL 98117965 not registered Live/Pending |
MOFAIP, LLC 2023-08-04 |
NOVEL 98094674 not registered Live/Pending |
Eastside Research, LLC 2023-07-20 |
NOVEL 97290051 not registered Live/Pending |
Novel LLC 2022-03-01 |
NOVEL 97287209 not registered Live/Pending |
Novel LLC 2022-02-28 |
NOVEL 90903317 not registered Live/Pending |
Novel Goods LLC 2021-08-26 |
NOVEL 90903315 not registered Live/Pending |
Novel Goods LLC 2021-08-26 |
NOVEL 90582043 not registered Live/Pending |
Blue Cross and Blue Shield of South Carolina, Inc. 2021-03-16 |
NOVEL 90458282 not registered Live/Pending |
Novel Energy Solutions L. L. C. 2021-01-11 |
NOVEL 90458246 not registered Live/Pending |
Novel Energy Solutions L. L. C. 2021-01-11 |
NOVEL 90350945 not registered Live/Pending |
Crescent Communities II, LLC 2020-12-01 |
NOVEL 88128325 not registered Live/Pending |
Two Orchards, LLC 2018-09-23 |
NOVEL 87978508 5588220 Live/Registered |
CRESCENT COMMUNITIES, LLC 2017-08-08 |