Primus Spinal Fixation System
Spinal Elements, Inc. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Carlsbad
- Advisory committee description
- Orthopedic
- Address 1
- 3115 Melrose Dr. Suite 200
- Statement or summary
- Summary
- Product code
- NKB
- Zip code
- 92010
- Applicant
- Spinal Elements, Inc.
- Decision date
- 2025-02-21
- Decision code
- SESE
- Country code
- US
- Device name
- Primus Spinal Fixation System
- Advisory committee
- OR
- Contact
- Cheryl Allen
- K number
- K243916
- State
- CA
- Date received
- 2024-12-20
- Review advisory committee
- OR
- Postal code
- 92010
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3070
- Device class
- 2
- Registration number
- 9617297, 3007604895, 1226544, 3002806603, 3007993775, 3007485169, 3006846753, 3011221483, 3010866843, 1000493591, 3009554293, 3005819474, 9615766, 3006563559, 3017780544, 3015869121, 3043543260, 3010370880, 3010646402, 2531477, 3013514648, 3036756245, 3034676720, 3014387294, 3013546462, 1828288, 3011556898, 3015941638, 3024999441, 3009882462, 3022518322, 2133687, 3008526708, 3006217744, 3016443334, 3010120326, 3004893332, 2531195, 2530808, 2028632 +376 more
- FEI number
- 3000718490, 3007604895, 3002806603, 3007993775, 1000069183, 3007485169, 3006846753, 3011221483, 1000143502, 3010866843, 3003690049, 3005568854, 1000493591, 3009554293, 3005532635, 3005819474, 3006563559, 3003112432, 3017780544, 3015869121, 3043543260, 3010370880, 3010646402, 3013514648, 3036756245, 3034676720, 3014387294, 3013546462, 1828288, 3011556898, 3024999441, 3009882462, 3022518322, 3008526708, 3006217744, 3016443334, 3010120326, 3004893332, 3002980729, 3016244279 +376 more