FDA UDI
In Commercial Distribution
🇺🇸 United States
K2M Fenestrated Tap System
DI: 10888857530089
·
Model: PRO-1117-05
·
K2M, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- K2M Fenestrated Tap System
- Primary DI
- 10888857530089
- Version / Model
- PRO-1117-05
- Catalog Number
- PRO-1117-05
- Company Name
- K2M, INC.
- Labeler DUNS
- 146060863
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-06
- Public Version
- 1
- Public Version Date
- 2021-08-16
- Public Version Status
- New
- Public Device Record Key
- 1970bb84-4735-4247-8edc-7186f90c13c8
Device Description
Tap, Fenestrated Size Ø7.5
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
- No
- 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 |
|---|---|---|---|---|
| KNW | INSTRUMENT, BIOPSY | Gastroenterology, Urology | 876.1075 | 2 |
| OAR | Injector, vertebroplasty (does not contain cement) | Orthopedic | 888.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61300 | Internal spinal fixation procedure kit, single-use | A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888857530089 | GS1 |
Customer Contacts
- Phone
- +1(571)919-2000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152872 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 7.5 | Millimeter |