Identity
- Trade Name
- SPIRA®-O Open Matrix OLIF FDA UDI
- Generic Name
- Surgical mallet FDA UDI
- Device Name
- Slap hammer Cap, Articulating Inserter FDA UDI
- Model / Reference
- SPO-103-003 FDA UDI
- Description
- Slap hammer Cap, Articulating Inserter FDA UDI
Identifiers
- Primary DI / UDI-DI
- B030SPO1030030 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Surgical mallet FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical mallet
SPIRA®-O Open Matrix OLIF by Camber Spine Technologies — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical mallet.
- Sklar — Sklar Corporation · Class I
- HNM MEDICAL — HNM STAINLESS, LLC. · Class I
- Salvin Dental Specialties — SALVIN DENTAL SPECIALTIES, LLC · Class I
- KMEDIC — TELEFLEX INCORPORATED · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Symmetry Surgical — SYMMETRY SURGICAL INC. · Class I
- Buxton BioMedical — BUXTON BIOMEDICAL, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Camber Spine Technologies
Sources (1)
- FDA UDI 5066facb-824b-4940-b11d-9c070d48b0cb 34 fields · synced May 30, 2026