Identity
- Trade Name
- Stealth All-Suture Anchor FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- Stealth All-Suture Anchor, with two 1.5mm Suture Tapes FDA UDI
- Model / Reference
- 285949 FDA UDI
- Description
- Stealth All-Suture Anchor, with two 1.5mm Suture Tapes FDA UDI
Identifiers
- Catalog Number
- 285949 FDA UDI
- Primary DI / UDI-DI
- 00811714036373 FDA UDI
- 510(k) Number
- K230094 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Stealth All-Suture Anchor by Responsive Orthopedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
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Cleared under the same submission
K230094 also covers:
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 |
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Manufacturer
- Manufacturer
- Responsive Orthopedics Llc
Sources (1)
- FDA UDI 31446fed-1e03-4ccd-8812-5787214e5ed4 35 fields · synced May 30, 2026