Primary Device ID | 00190376528670 |
NIH Device Record Key | 0d8c5dcf-4f37-4b35-9866-f43ee235b0a3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ATEC Posterior Navigation Disc Prep Instruments |
Version Model Number | 244-05-07092200-N |
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 | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com | |
Phone | +1(760)431-9286 |
Regulatory@alphatecspine.com |
Length | 22 Millimeter |
Height | 7 Millimeter |
Width | 9 Millimeter |
Length | 22 Millimeter |
Height | 7 Millimeter |
Width | 9 Millimeter |
Length | 22 Millimeter |
Height | 7 Millimeter |
Width | 9 Millimeter |
Length | 22 Millimeter |
Height | 7 Millimeter |
Width | 9 Millimeter |
Length | 22 Millimeter |
Height | 7 Millimeter |
Width | 9 Millimeter |
Length | 22 Millimeter |
Height | 7 Millimeter |
Width | 9 Millimeter |
Length | 22 Millimeter |
Height | 7 Millimeter |
Width | 9 Millimeter |
Length | 22 Millimeter |
Height | 7 Millimeter |
Width | 9 Millimeter |
Length | 22 Millimeter |
Height | 7 Millimeter |
Width | 9 Millimeter |
Length | 22 Millimeter |
Height | 7 Millimeter |
Width | 9 Millimeter |
Length | 22 Millimeter |
Height | 7 Millimeter |
Width | 9 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00190376528670 [Primary] |
OLO | Orthopedic stereotaxic instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00190376528670]
Moist Heat or Steam Sterilization
[00190376528670]
Moist Heat or Steam Sterilization
[00190376528670]
Moist Heat or Steam Sterilization
[00190376528670]
Moist Heat or Steam Sterilization
[00190376528670]
Moist Heat or Steam Sterilization
[00190376528670]
Moist Heat or Steam Sterilization
[00190376528670]
Moist Heat or Steam Sterilization
[00190376528670]
Moist Heat or Steam Sterilization
[00190376528670]
Moist Heat or Steam Sterilization
[00190376528670]
Moist Heat or Steam Sterilization
[00190376528670]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-29 |
Device Publish Date | 2024-04-20 |
00190376588131 | Posterior Navigated Disc Prep Supplementary Set |
00190376588124 | Posterior Navigated Disc Prep Instrument Set |
00190376542560 | POST NAV RING CURETTE, 10mm |
00190376531717 | NAV OFFSET HANDLE |
00190376530260 | NAV OFFSET HANDLE ADAPTER |
00190376530055 | POST NAV RING CURETTE, 8mm |
00190376530048 | POST NAV RING CURETTE, 6mm |
00190376529295 | POST NAV ROTATING DISTRACTOR, 14mm |
00190376529288 | POST NAV ROTATING DISTRACTOR, 13mm |
00190376529271 | POST NAV ROTATING DISTRACTOR, 12mm |
00190376529264 | POST NAV ROTATING DISTRACTOR, 11mm |
00190376529257 | POST NAV ROTATING DISTRACTOR, 10mm |
00190376529240 | POST NAV ROTATING DISTRACTOR, 9mm |
00190376529233 | POST NAV ROTATING DISTRACTOR, 8mm |
00190376529226 | POST NAV ROTATING DISTRACTOR, 7mm |
00190376529219 | POST NAV ROTATING DISTRACTOR, 6mm |
00190376529189 | POST NAV OSTEOTOME, 12mm |
00190376529158 | POST NAV OSTEOTOME, 6mm |
00190376529141 | POST NAV ROTATING SHAVER, 14MM |
00190376529134 | POST NAV ROTATING SHAVER, 13MM |
00190376529127 | POST NAV ROTATING SHAVER, 12MM |
00190376529110 | POST NAV ROTATING SHAVER, 11MM |
00190376529103 | POST NAV ROTATING SHAVER, 10MM |
00190376529097 | POST NAV ROTATING SHAVER, 9MM |
00190376529080 | POST NAV ROTATING SHAVER, 8MM |
00190376529073 | POST NAV ROTATING SHAVER, 7MM |
00190376529066 | POST NAV ROTATING SHAVER, 6MM |
00190376529042 | POST NAV RIGHT-BEND CUP CURETTE, SIZE 2 |
00190376529035 | POST NAV LEFT-BEND CUP CURETTE, SIZE 2 |
00190376529028 | POST NAV PUSH CUP CURETTE, SIZE 2 |
00190376529004 | POST NAV STRAIGHT CUP CURETTE, SIZE 2 |
00190376528984 | POST NAV ENDPLATE SCRAPER, 10mm |
00190376528977 | POST NAV ENDPLATE SCRAPER, 8mm |
00190376528960 | POST NAV ENDPLATE SCRAPER, 6mm |
00190376528861 | POST NAV PS Trial 11 x 9 x 22mm, 15° |
00190376528854 | POST NAV PS Trial 11 x 9 x 22mm, 10° |
00190376528847 | POST NAV PS Trial 11 x 9 x 22mm, 5° |
00190376528830 | POST NAV PS Trial 11 x 9 x 22mm, 0° |
00190376528823 | POST NAV PS Trial 10 x 9 x 22mm, 15° |
00190376528816 | POST NAV PS Trial 10 x 9 x 22mm, 10° |
00190376528809 | POST NAV PS Trial 10 x 9 x 22mm, 5° |
00190376528793 | POST NAV PS Trial 10 x 9 x 22mm, 0° |
00190376528786 | POST NAV PS Trial 9 x 9 x 22mm, 15° |
00190376528779 | POST NAV PS Trial 9 x 9 x 22mm, 10° |
00190376528762 | POST NAV PS Trial 9 x 9 x 22mm, 5° |
00190376528755 | POST NAV PS Trial 9 x 9 x 22mm, 0° |
00190376528748 | POST NAV PS Trial 8 x 9 x 22mm, 15° |
00190376528731 | POST NAV PS Trial 8 x 9 x 22mm, 10° |
00190376528724 | POST NAV PS Trial 8 x 9 x 22mm, 5° |
00190376528717 | POST NAV PS Trial 8 x 9 x 22mm, 0° |