MOUNTAINEER 188312221

GUDID 10705034356211

MOUNTAINEER OCT SPINAL SYSTEM ANGLED LATERAL OFFSET CONNECTOR 23.4mm

DEPUY SPINE, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10705034356211
• NIH Device Record Key: 2440be11-ffda-4461-abaf-bb8bad7d7a3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOUNTAINEER
• Version Model Number: 188312221
• Catalog Number: 188312221
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, 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: 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

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034356211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042508

FDA Product Code

• NKG: Orthosis, cervical pedicle screw spinal fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10705034356211]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-04
• Device Publish Date: 2015-09-24

On-Brand Devices [MOUNTAINEER]

• 10705034307053: MOUNTAINEER OCT SPINAL SYSTEM EXTENDED TAB REMOVER
• 10705034221816: MOUNTAINEER OCT SPINAL SYSTEM INSERTER
• 10705034221793: MOUNTAINEER OCT SPINAL SYSTEM INSERTER
• 10705034221786: MOUNTAINEER OCT SPINAL SYSTEM INSERTER, STRAIGHT
• 10705034221557: MOUNTAINEER OCT SPINAL SYSTEM HOOK INSERTER
• 10705034221502: MOUNTAINEER OCT SPINAL SYSTEM DISTRACTOR
• 10705034221434: MOUNTAINEER OCT SPINAL SYSTEM INSERTER X15
• 10705034307060: MOUNTAINEER OCT SPINAL SYSTEM RING FOR EXTENDED TAB IMPLANTS
• 10705034356211: MOUNTAINEER OCT SPINAL SYSTEM ANGLED LATERAL OFFSET CONNECTOR 23.4mm
• 10705034221946: MOUNTAINEER LAMINOPLASTY SYSTEM PLATE BENDING IRON, THRU
• 10705034221939: MOUNTAINEER LAMINOPLASTY SYSTEM PLATE BENDING IRON, BLIND
• 10705034307084: MOUNTAINEER LAMINOPLASTY SYSTEM ALLOGRAFT HOLDER
• 10705034221960: MOUNTAINEER LAMINOPLASTY SYSTEM PLATE HOLDER, TWEEZER
• 10705034221762: MOUNTAINEER OCT SPINAL SYSTEM DRILL GUIDE STOP
• 10705034221731: MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL DRILL GUIDE 14 / 16mm
• 10705034221724: MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL DRILL GUIDE 10 / 12mm
• 10705034221717: MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL DRILL GUIDE 6 / 8mm
• 10705034221700: MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL DRILL GUIDE
• 10705034221571: MOUNTAINEER OCT SPINAL SYSTEM DRILL GUIDE
• 10705034221564: MOUNTAINEER OCT SPINAL SYSTEM DRILL GUIDE
• 10705034221540: MOUNTAINEER OCT SPINAL SYSTEM HOOK HOLDER
• 10705034221199: MOUNTAINEER OCT SPINAL SYSTEM FIXED DRILL 16mm
• 10705034221182: MOUNTAINEER OCT SPINAL SYSTEM FIXED DRILL 14mm
• 10705034221175: MOUNTAINEER OCT SPINAL SYSTEM FIXED DRILL 12mm
• 10705034221137: MOUNTAINEER OCT SPINAL SYSTEM DRILL GUIDE STOP
• 10705034221120: MOUNTAINEER OCT SPINAL SYSTEM DRILL GUIDE
• 10705034307145: MOUNTAINEER OCT SPINAL SYSTEM EXTENDED TAB SCREW CADDY 3.5mm
• 10705034307138: MOUNTAINEER OCT SPINAL SYSTEM SCREW CADDY 3.5mm
• 10705034222585: MOUNTAINEER OCT SPINAL SYSTEM INSTRUMENT CASE AND TRAY
• 10705034222554: MOUNTAINEER LAMINOPLASTY SYSTEM INLINE PLATE CADDY
• 10705034222547: MOUNTAINEER LAMINOPLASTY SYSTEM OFFSET PLATE CADDY
• 10705034222530: MOUNTAINEER LAMINOPLASTY SYSTEM SCREW CADDY 2.6mm
• 10705034222523: MOUNTAINEER LAMINOPLASTY SYSTEM SCREW CADDY 2.3mm
• 10705034222516: MOUNTAINEER LAMINOPLASTY SYSTEM DRILL CADDY
• 10705034222509: MOUNTAINEER LAMINOPLASTY SYSTEM CASE LID
• 10705034222493: MOUNTAINEER LAMINOPLASTY SYSTEM CASE
• 10705034222486: MOUNTAINEER OCT SPINAL SYSTEM HOOKED DRILL GUIDE CASE 482mm x 47mm
• 10705034222479: MOUNTAINEER OCT SPINAL SYSTEM ROD CADDY
• 10705034222462: MOUNTAINEER OCT SPINAL SYSTEM CONNECTOR CADDY
• 10705034222455: MOUNTAINEER OCT SPINAL SYSTEM MEDIAL/LATERAL SCREW CADDY 4.35mm
• 10705034222424: MOUNTAINEER OCT SPINAL SYSTEM IMPLANT CASE/TRAY
• 10705034222400: MOUNTAINEER OCT SPINAL SYSTEM SCREW CADDY 3.5mm
• 10705034222363: MOUNTAINEER OCT SPINAL SYSTEM IMPLANT CASE/TRAY
• 10705034222325: MOUNTAINEER OCT SPINAL SYSTEM OCCIPITO CERVICO CADDY SET
• 10705034222318: MOUNTAINEER OCT SPINAL SYSTEM OCCIPITO CERVICO BOTTOM TRAY
• 10705034222301: MOUNTAINEER OCT SPINAL SYSTEM OCCIPITO CERVICO TOP TRAY
• 10705034222295: MOUNTAINEER OCT SPINAL SYSTEM IMPL./INSTR. CASE AND TRAY
• 10705034222288: MOUNTAINEER OCT SPINAL SYSTEM ONE LEVEL TRAY WITH LID 482mm x 47mm
• 10705034222271: MOUNTAINEER OCT SPINAL SYSTEM LID
• 10705034222264: MOUNTAINEER OCT SPINAL SYSTEM ANCILLARY TRAY