FDA UDI
In Commercial Distribution
🇺🇸 United States
SPIRA®-A Integrated
DI: B030SAZ1032050
·
Model: SAZ-103-205
·
CAMBER SPINE TECHNOLOGIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- SPIRA®-A Integrated
- Primary DI
- B030SAZ1032050
- Version / Model
- SAZ-103-205
- Company Name
- CAMBER SPINE TECHNOLOGIES, LLC
- Labeler DUNS
- 054205979
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-01
- Public Version
- 1
- Public Version Date
- 2025-08-11
- Public Version Status
- New
- Public Device Record Key
- 5e5ebf0b-232d-4c4c-b0dc-686b1cd98dac
Device Description
SPIRA®-A Integrated, Anchor Ram Cap
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47814 | Orthopaedic implantation hammering attachment | A surgical instrument designed to be attached to another surgical implantation instrument or directly to an orthopaedic implant to provide a surface on which an operating surgeon can make strikes, with a surgical hammer or mallet, to insert an orthopaedic implant (e.g., an intramedullary nail). It is typically made of high-grade stainless steel and typically in the form of a cylindrical shaft with a threaded portion at the distal end (i.e., threaded into the implant or connected to the implantation instrument) and a broader, robust striking head (surface) at the proximal end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B030SAZ1032050 | HIBCC |
Customer Contacts
- Phone
- +1 (484) 427-7060
- [email protected]