| Primary Device ID | 00190376642970 |
| NIH Device Record Key | a153ed78-99c7-400c-b9cd-89dbf952dbe1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osteotomy Instruments |
| Version Model Number | 152-01-100-16 |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376642970 [Primary] |
| GFI | OSTEOTOME, MANUAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
[00190376642970]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-11 |
| Device Publish Date | 2025-04-03 |
| 00190376538549 | Lateral Corpectomy Osteotomy Instruments Alpha System |
| 00190376538532 | Posterior Corpectomy Osteotomy Instruments Alpha System |
| 00190376517148 | ADJUSTABLE VB SPOON RETRACTOR, 30mm |
| 00190376517131 | ADJUSTABLE VB SPOON RETRACTOR, 20mm |
| 00190376517124 | ADJUSTABLE VB SPOON RETRACTOR, 15mm |
| 00190376516455 | CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 10 |
| 00190376516448 | CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 9 |
| 00190376516431 | CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 8 |
| 00190376516424 | CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 7 |
| 00190376516417 | CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 5 |
| 00190376516400 | CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 4 |
| 00190376516394 | CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 3 |
| 00190376516387 | CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 2 |
| 00190376515953 | LIF Osteotome, Curved 40mm |
| 00190376515939 | LIF Osteotome, Curved 38mm |
| 00190376515915 | LIF Osteotome, Curved 36mm |
| 00190376515892 | LIF Osteotome, Curved 34mm |
| 00190376515878 | LIF Osteotome, Curved 32mm |
| 00190376515854 | LIF Osteotome, Curved 6mm |
| 00190376515830 | LIF Osteotome, Straight 40mm |
| 00190376515816 | LIF Osteotome, Straight 38mm |
| 00190376515793 | LIF Osteotome, Straight 36mm |
| 00190376515779 | LIF Osteotome, Straight 34mm |
| 00190376515755 | LIF Osteotome, Straight 32mm |
| 00190376515731 | LIF Osteotome, Straight 6mm |
| 00190376515717 | Osteotome, Curved 40mm |
| 00190376515694 | Osteotome, Curved 38mm |
| 00190376515670 | Osteotome, Curved 36mm |
| 00190376515656 | Osteotome, Curved 34mm |
| 00190376515632 | Osteotome, Curved 32mm |
| 00190376515618 | Osteotome, Curved 6mm |
| 00190376515595 | Osteotome, Straight 40mm |
| 00190376515571 | Osteotome, Straight 38mm |
| 00190376515557 | Osteotome, Straight 36mm |
| 00190376515533 | Osteotome, Straight 34mm |
| 00190376515519 | Osteotome, Straight 32mm |
| 00190376515496 | Osteotome, Straight 6mm |
| 00190376514260 | Posterior Vertebral Body Punch, 30mm |
| 00190376514253 | Posterior Vertebral Body Punch, 25mm |
| 00190376514246 | Cup Curette, Straight, Up Angled, Size 06 |
| 00190376514239 | Right Angle Osteotome, 7mm |
| 00190376513164 | LIF Osteotome, Curved 30mm |
| 00190376513157 | LIF Osteotome, Curved 28mm |
| 00190376513140 | LIF Osteotome, Curved 26mm |
| 00190376513133 | LIF Osteotome, Curved 24mm |
| 00190376513126 | LIF Osteotome, Curved 22mm |
| 00190376513119 | LIF Osteotome, Curved 20mm |
| 00190376513102 | LIF Osteotome, Curved 18mm |
| 00190376513096 | LIF Osteotome, Curved 16mm |
| 00190376513089 | LIF Osteotome, Curved 14mm |