Identity
- Trade Name
- THUMB MOD HEAD TITANIUM 15MM+2 FDA UDI
- Generic Name
- Carpometacarpal interpositional spacer, non-bioabsorbable FDA UDI
- Model / Reference
- 17809 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209178090 FDA UDI
- 510(k) Number
- K061089 FDA UDI
- FDA Product Code
- KYI FDA UDI
- GMDN Term
- Carpometacarpal interpositional spacer, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3770 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Carpometacarpal interpositional spacer, non-bioabsorbable
Thumb Mod Head Titanium 15mm+2 by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carpometacarpal interpositional spacer, non-bioabsorbable.
- CMI — TORNIER, INC. · Class II
- CMI — TORNIER, INC. · Class II
- CMI — TORNIER, INC. · Class II
- THUMB MOD HEAD 15mm — BIOPRO, INC. · Class II
- THUMB MOD STEM TITANIUM TPS 8.5mm — BIOPRO, INC. · Class II
- THUMB MOD HEAD TITANIUM 14MM+4 — BIOPRO, INC. · Class II
- THUMB MOD STEM TITANIUM TPS 7.5mm — BIOPRO, INC. · Class II
- THUMB MOD HEAD TITANIUM 12MM+4 — BIOPRO, INC. · Class II
Cleared under the same submission
K061089 also covers:
- Alignment Guide W/ Pin — BIOPRO, INC.
- Allen Key — BIOPRO, INC.
- Assembly Block — BIOPRO, INC.
- BioPro — BIOPRO, INC.
- BioPro — BIOPRO, INC.
- BioPro — BIOPRO, INC.
- BioPro — BIOPRO, INC.
- Bone Spatula — BIOPRO, INC.
- Burr Adaptor Microchoice — BIOPRO, INC.
- Burr Adaptor Stryker TPS — BIOPRO, INC.
- Burr Adaptor-Microaire — BIOPRO, INC.
- Burr Coarse 12MM — BIOPRO, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI 26104dc7-76bc-466e-8b79-5e998210403c 33 fields · synced Jun 8, 2026