Identity
- Trade Name
- Tiger Shark System FDA UDI
- Generic Name
- Intervertebral-body internal spinal fixation system FDA UDI
- Device Name
- TIGER SHARK,STERILE,STR,9X32X13,6 DEG FDA UDI
- Model / Reference
- S-PT34-32136 FDA UDI
- Description
- TIGER SHARK,STERILE,STR,9X32X13,6 DEG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840996166317 FDA UDI
- 510(k) Number
- K172816 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Intervertebral-body internal spinal fixation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 13 Millimeter FDA UDIWidth — 9 Millimeter FDA UDILength — 32 Millimeter FDA UDI
Category: Intervertebral-body internal spinal fixation system
Tiger Shark System by Choicespine, LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intervertebral-body internal spinal fixation system.
- Tyber Medical — Tyber Medical · Class II
- BP® — ZIMMER SPINE, INC. · Class II
- Maxima™ ACP System — CG MedTech Co., Ltd. · Class II
- Tyber Medical — Tyber Medical · Class II
- Tyber Medical — Tyber Medical · Class II
- Maxima™ ACP System — CG MedTech Co., Ltd. · Class II
- Fortitude® — ZIMMER SPINE, INC. · Class II
- Maxima™ ACP System — CG MedTech Co., Ltd. · Class II
Cleared under the same submission
K172816 also covers:
- TIGER SHARK Cervical System — Choicespine, LP
- TIGER SHARK SYSTEM — Choicespine, LP
- TIGER SHARK SYSTEM — Choicespine, LP
- TIGER SHARK SYSTEM — Choicespine, LP
- TIGERSHARK — Choicespine, LP
- TIGERSHARK — Choicespine, LP
- TIGERSHARK — Choicespine, LP
- TIGERSHARK — Choicespine, LP
- TiGER SHARK Interbody Fusion System — Choicespine, LP
- TiGER SHARK Interbody Fusion System — Choicespine, LP
- TiGER SHARK Interbody Fusion System — Choicespine, LP
- TiGER SHARK Interbody Fusion System — Choicespine, LP
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Choicespine, LP
Sources (1)
- FDA UDI 57fc49f1-45b3-488a-8c32-5bdcfa85ee0e 36 fields · synced Jun 8, 2026