Primary Device ID | B084AC2121410070 |
NIH Device Record Key | 02ffe275-52c1-4829-b99c-f8b162561bcb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Anterior Cervical IBFD |
Version Model Number | 12D x 14W x 10H x 7L, PEEK-HA |
Catalog Number | AC2-121410-07 |
Company DUNS | 080551837 |
Company Name | KEOS |
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 | true |
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 Issuing Agency | Device ID |
---|---|
HIBCC | B084AC2121410070 [Primary] |
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
[B084AC2121410070]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-29 |
Device Publish Date | 2023-12-21 |
B084AC1111312070 | 11D x 13W x 12H x 7L, PEEK |
B084AC1111312040 | 11D x 13W x 12H x 4L, PEEK |
B084AC1111312000 | 11D x 13W x 12H x 0L, PEEK |
B084AC1111311070 | 11D x 13W x 11H x 7L, PEEK |
B084AC1111311040 | 11D x 13W x 11H x 4L, PEEK |
B084AC1111311000 | 11D x 13W x 11H x 0L, PEEK |
B084AC1111310070 | 11D x 13W x 10H x 7L, PEEK |
B084AC1111310040 | 11D x 13W x 10H x 4L, PEEK |
B084AC1111310000 | 11D x 13W x 10H x 0L, PEEK |
B084AC1111309070 | 11D x 13W x 09H x 7L, PEEK |
B084AC1111309040 | 11D x 13W x 09H x 4L, PEEK |
B084AC1111309000 | 11D x 13W x 09H x 0L, PEEK |
B084AC1111308070 | 11D x 13W x 08H x 7L, PEEK |
B084AC1111308040 | 11D x 13W x 08H x 4L, PEEK |
B084AC1111308000 | 11D x 13W x 08H x 0L, PEEK |
B084AC1111307070 | 11D x 13W x 07H x 7L, PEEK |
B084AC1111307040 | 11D x 13W x 07H x 4L, PEEK |
B084AC1111307000 | 11D x 13W x 07H x 0L, PEEK |
B084AC1111306070 | 11D x 13W x 06H x 7L, PEEK |
B084AC1111306040 | 11D x 13W x 06H x 4L, PEEK |
B084AC1111306000 | 11D x 13W x 06H x 0L, PEEK |
B084AC1111305070 | 11D x 13W x 05H x 7L, PEEK |
B084AC1111305040 | 11D x 13W x 05H x 4L, PEEK |
B084AC1111305000 | 11D x 13W x 05H x 0L, PEEK |
B084AC2141612070 | 14D x 16W x 12H x 7L, PEEK-HA |
B084AC2141611070 | 14D x 16W x 11H x 7L, PEEK-HA |
B084AC2141610070 | 14D x 16W x 10H x 7L, PEEK-HA |
B084AC2141609070 | 14D x 16W x 09H x 7L, PEEK-HA |
B084AC2141608070 | 14D x 16W x 08H x 7L, PEEK-HA |
B084AC2141607070 | 14D x 16W x 07H x 7L, PEEK-HA |
B084AC2141606070 | 14D x 16W x 06H x 7L, PEEK-HA |
B084AC2141605070 | 14D x 16W x 05H x 7L, PEEK-HA |
B084AC2121412070 | 12D x 14W x 12H x 7L, PEEK-HA |
B084AC2121411070 | 12D x 14W x 11H x 7L, PEEK-HA |
B084AC2121410070 | 12D x 14W x 10H x 7L, PEEK-HA |
B084AC2121409070 | 12D x 14W x 09H x 7L, PEEK-HA |
B084AC2121408070 | 12D x 14W x 08H x 7L, PEEK-HA |
B084AC2121407070 | 12D x 14W x 07H x 7L, PEEK-HA |
B084AC2121406070 | 12D x 14W x 06H x 7L, PEEK-HA |
B084AC2121405070 | 12D x 14W x 05H x 7L, PEEK-HA |
B084AC1121412070 | 12D x 14W x 12H x 7L, PEEK |
B084AC1121412040 | 12D x 14W x 12H x 4L, PEEK |
B084AC1121412000 | 12D x 14W x 12H x 0L, PEEK |
B084AC1121411070 | 12D x 14W x 11H x 7L, PEEK |
B084AC1121411040 | 12D x 14W x 11H x 4L, PEEK |
B084AC1121411000 | 12D x 14W x 11H x 0L, PEEK |
B084AC1121410070 | 12D x 14W x 10H x 7L, PEEK |
B084AC1121410040 | 12D x 14W x 10H x 4L, PEEK |
B084AC1121410000 | 12D x 14W x 10H x 0L, PEEK |
B084AC1121409070 | 12D x 14W x 09H x 7L, PEEK |