| Primary Device ID | 00810016801375 |
| NIH Device Record Key | c95e0a4d-db68-4ecc-bb75-f399d42cd41f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Accufuse Cervical System |
| Version Model Number | C181505 |
| Catalog Number | C181505 |
| Company DUNS | 056248579 |
| Company Name | ABSOLUTE ADVANTAGE MEDICAL, LLC |
| 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 |
|---|---|
| GS1 | 00810016801375 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810016801375]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-12-31 |
| 00810016801207 | Case - Lid |
| 00810016800309 | Cervical Screw Variable 4.5x14mm Sharp |
| 00810016801269 | Variable Screw Implant Caddy with Lid |
| 00810016801252 | Fixed Screw Implant Caddy with Lid |
| 00810016801245 | Plate Implant Caddy with Lid |
| 00810016801238 | Cage Implant Caddy with Lid |
| 00810016801221 | Case Implant Tray |
| 00810016801214 | Case Base Instrument Tray |
| 00810016801191 | System Case |
| 00810016801184 | Cage - Plate Trial 12mm |
| 00810016801177 | Cage - Plate Trial 11mm |
| 00810016801160 | Cage - Plate Trial 10mm |
| 00810016801153 | Cage - Plate Trial 9mm |
| 00810016801146 | Cage - Plate Trial 8mm |
| 00810016801139 | Cage - Plate Trial 7mm |
| 00810016801122 | Cage - Plate Trial 6mm |
| 00810016801115 | Cage - Plate Trial 5mm |
| 00810016801108 | Cover Plate Sheath |
| 00810016801092 | Dual Drill Guide - Angled |
| 00810016801085 | Cage Plate Fastener |
| 00810016801078 | Cage Tamp |
| 00810016801061 | Cage Trial 12mm |
| 00810016801054 | Cage Trial 11mm |
| 00810016801047 | Cage Trial 10mm |
| 00810016801030 | Cage Trial 9mm |
| 00810016801023 | Cage Trial 8mm |
| 00810016801016 | Cage Trial 7mm |
| 00810016801009 | Cage Trial 6mm |
| 00810016800996 | Cage Trial 5mm |
| 00810016800989 | Dual Drill Guide Block-14mm Plate |
| 00810016800972 | Dual Drill Guide Block-13mm Plate |
| 00810016800965 | Dual Drill Guide Block-12mm Plate |
| 00810016800958 | Dual Drill Guide Block-11mm Plate |
| 00810016800941 | Dual Drill Guide Block-10mm Plate |
| 00810016800934 | Dual Drill Guide Block-9mm Plate |
| 00810016800927 | Dual Drill Guide Block-8mm Plate |
| 00810016800910 | Dual Drill Guide Block-7mm Plate |
| 00810016800903 | Torque Limiter Handle -13 in.lbs/1.5 N-m |
| 00810016800897 | Screw Driver - Hexalobe #15 |
| 00810016800880 | Cage Only Inserter |
| 00810016800873 | Dual Drill Guide, Straight |
| 00810016800866 | Single Drill Guide, Variable |
| 00810016800859 | Small AO Chuck Handle-Non Ratchet |
| 00810016800842 | Bone Tap Ø4.0x12mm |
| 00810016800835 | Drill Bit Ø2.4x16mm |
| 00810016800828 | Drill Bit Ø2.4x14mm |
| 00810016800811 | Drill Bit Ø2.4x12mm |
| 00810016800804 | Bone Awl, Open |
| 00810016800798 | Cervical PEEK 14mmx12mmx12mm 7° lordosis |
| 00810016800781 | Cervical PEEK 14mmx12mmx10mm 7° lordosis |