FDA UDI
In Commercial Distribution
🇺🇸 United States
C-PS Peek Optima Cervical Interbody Spacer
DI: M696CPS620S0
·
Model: CPS-620S
·
ORTHOPAEDIC IMPLANT COMPANY, THE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- C-PS Peek Optima Cervical Interbody Spacer
- Primary DI
- M696CPS620S0
- Version / Model
- CPS-620S
- Company Name
- ORTHOPAEDIC IMPLANT COMPANY, THE
- Labeler DUNS
- 070061160
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-01
- Public Version
- 6
- Public Version Date
- 2021-04-21
- Public Version Status
- Update
- Public Device Record Key
- 0f79b876-52fe-4df3-8369-115d3c9a6258
Device Description
CERVICAL CAGE INSERTER
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47807 | Surgical implant/trial-implant/sizer holder, reusable | A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M696CPS620S0 | HIBCC |
Customer Contacts
- Phone
- 775 636 8281
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092540 | 000 |