| Primary Device ID | M697C03402280 |
| NIH Device Record Key | 80df1cee-049e-41d9-93c0-d4910e2a2e2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Calix Spinal Implant System |
| Version Model Number | C034-0228 |
| Company DUNS | 610042587 |
| Company Name | X-SPINE SYSTEMS, 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(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com | |
| Phone | +1(937)847-8400 |
| orders@x-spine.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M697C03402280 [Direct Marking] |
| HIBCC | M697C03402281 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
[M697C03402280]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2016-06-29 |
| M697X0340397PCSTR1 | 26mm L x 10mm W x 16mm H; 5° Calix-PLIF, PC |
| M697X0340396PCSTR1 | 26mm L x 10mm W x 15mm H; 5° Calix-PLIF, PC |
| M697X0340395PCSTR1 | 26mm L x 10mm W x 14mm H; 5° Calix-PLIF, PC |
| M697X0340394PCSTR1 | 26mm L x 10mm W x 13mm H; 5° Calix-PLIF, PC |
| M697X0340393PCSTR1 | 26mm L x 10mm W x 12mm H; 5° Calix-PLIF, PC |
| M697X0340392PCSTR1 | 26mm L x 10mm W x 11mm H; 5° Calix-PLIF, PC |
| M697X0340391PCSTR1 | 26mm L x 10mm W x 10mm H; 5° Calix-PLIF, PC |
| M697X0340390PCSTR1 | 26mm L x 10mm W x 9mm H; 5° Calix-PLIF, PC |
| M697X0340389PCSTR1 | 26mm L x 10mm W x 8mm H; 5° Calix-PLIF, PC |
| M697X0340388PCSTR1 | 26mm L x 10mm W x 7mm H; 5° Calix-PLIF, PC |
| M697X0340387PCSTR1 | 26mm L x 10mm W x 6mm H; 5° Calix-PLIF, PC |
| M697X0340290PCSTR1 | 28mm x 10mm x 16mm Calix-TLIF, PC |
| M697X0340289PCSTR1 | 28mm x 10mm x 15mm Calix-TLIF, PC |
| M697X0340288PCSTR1 | 28mm x 10mm x 14mm Calix-TLIF, PC |
| M697X0340287PCSTR1 | 28mm x 10mm x 13mm Calix-TLIF, PC |
| M697X0340286PCSTR1 | 28mm x 10mm x 12mm Calix-TLIF, PC |
| M697X0340285PCSTR1 | 28mm x 10mm x 11mm Calix-TLIF, PC |
| M697X0340284PCSTR1 | 28mm x 10mm x 10mm Calix-TLIF, PC |
| M697X0340283PCSTR1 | 28mm x 10mm x 9mm Calix-TLIF, PC |
| M697X0340282PCSTR1 | 28mm x 10mm x 8mm Calix-TLIF, PC |
| M697X0340281PCSTR1 | 28mm x 10mm x 7mm Calix-TLIF, PC |
| M697X0340280PCSTR1 | 28mm x 10mm x 6mm Calix-TLIF, PC |
| M697X0340253PCSTR1 | 26mm L x 10mm W x 16mm H; Calix-PLIF, PC |
| M697X0340249PCSTR1 | 26mm L x 10mm W x 15mm H; Calix-PLIF, PC |
| M697X0340248PCSTR1 | 26mm L x 10mm W x 13mm H; Calix-PLIF, PC |
| M697X0340247PCSTR1 | 26mm L x 10mm W x 11mm H; Calix-PLIF, PC |
| M697X0340246PCSTR1 | 26mm L x 10mm W x 9mm H; Calix-PLIF, PC |
| M697X0340245PCSTR1 | 26mm L x 10mm W x 7mm H; Calix-PLIF, PC |
| M697X0340244PCSTR1 | 26mm L x 10mm W x 14mm H; Calix-PLIF, PC |
| M697X0340243PCSTR1 | 26mm L x 10mm W x 12mm H; Calix-PLIF, PC |
| M697X0340242PCSTR1 | 26mm L x 10mm W x 10mm H; Calix-PLIF, PC |
| M697X0340241PCSTR1 | 26mm L x 10mm W x 8mm H; Calix-PLIF, PC |
| M697X0340240PCSTR1 | 26mm L x 10mm W x 6mm H; Calix-PLIF, PC |
| M697X0340181PCSTR1 | 22mm L x 10mm W x 16mm H; Calix-PLIF, PC |
| M697X0340180PCSTR1 | 22mm L x 10mm W x 15mm H; Calix-PLIF, PC |
| M697X0340179PCSTR1 | 22mm L x 10mm W x 14mm H; Calix-PLIF, PC |
| M697X0340178PCSTR1 | 22mm L x 10mm W x 13mm H; Calix-PLIF, PC |
| M697X0340177PCSTR1 | 22mm L x 10mm W x 12mm H; Calix-PLIF, PC |
| M697X0340176PCSTR1 | 22mm L x 10mm W x 11mm H; Calix-PLIF, PC |
| M697X0340175PCSTR1 | 22mm L x 10mm W x 10mm H; Calix-PLIF, PC |
| M697X0340174PCSTR1 | 22mm L x 10mm W x 9mm H; Calix-PLIF, PC |
| M697X0340173PCSTR1 | 22mm L x 10mm W x 8mm H; Calix-PLIF, PC |
| M697X0340172PCSTR1 | 22mm L x 10mm W x 7mm H; Calix-PLIF, PC |
| M697X0340171PCSTR1 | 22mm L x 10mm W x 6mm H; Calix-PLIF, PC |
| M697X03428900 | 26mm x 10mm x 16mm PLIF RASP ASSY |
| M697X03428890 | 26mm x 10mm x 15mm PLIF RASP ASSY |
| M697X03428880 | 26mm x 10mm x 14mm PLIF RASP ASSY |
| M697X03428870 | 26mm x 10mm x 13mm PLIF RASP ASSY |
| M697X03428860 | 26mm x 10mm x 12mm PLIF RASP ASSY |
| M697X03428850 | 26mm x 10mm x 11mm PLIF RASP ASSY |