OPTEFORM® Allograft Disc, 45mm x 5mm, 8cc 600-05-45
GUDID 10885862093219
Surgalign Spine Technologies, Inc.
Bone matrix implant, human-derived| Primary Device ID | 10885862093219 |
| NIH Device Record Key | 11156b81-a0c2-41b6-ac4b-9f1ae8005d56 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTEFORM® Allograft Disc, 45mm x 5mm, 8cc |
| Version Model Number | 002545 |
| Catalog Number | 600-05-45 |
| Company DUNS | 014520584 |
| Company Name | Surgalign Spine Technologies, 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 | true |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and -20 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10885862093219 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043421
FDA Product Code
| MQV | FILLER, BONE VOID, CALCIUM COMPOUND |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2015-11-06 |
Devices Manufactured by Surgalign Spine Technologies, Inc.
| 00840311208951 - Cortera | 2024-09-11 Tulip Adjuster, MIS, Distal, T |
| 00840311208968 - Cortera | 2024-09-11 Tab Adjuster, MIS, Proximal, T |
| 00840311236923 - Streamline OCT | 2023-10-13 Ø3.2mm x 100mm CoCr Rod |
| 00840311236930 - Streamline OCT | 2023-10-13 Ø3.2mm x 110mm CoCr Rod |
| 00840311236947 - Streamline OCT | 2023-10-13 Ø3.2mm x 120mm CoCr Rod |
| 00840311236954 - Streamline OCT | 2023-10-13 Ø3.2mm x 160mm CoCr Rod |
| 00840311236961 - Streamline OCT | 2023-10-13 Ø3.2mm x 180mm CoCr Rod |
| 00840311236978 - Streamline OCT | 2023-10-13 Ø3.2mm x 20mm CoCr Rod |
Trademark Results [OPTEFORM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTEFORM 75567452 2392670 Live/Registered |
EXACTECH, INC. 1998-10-09 |
OPTEFORM 75567452 2392670 Live/Registered |
Exactech, Inc. 1998-10-09 |
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