Osteoraptor / Ultrabraid
Osteoraptor Crvd 2.3MM 42 White
2manufacturers in China registered for this device type
3catalogue numbers in this listing
10510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K103309 |
| Record published | 2015-08-29 |
| Record revised | 2023-09-29 (version 8) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72203289 | In distribution | |
| 72202165 | In distribution | |
| 72201991 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 545 |
| Fix2Lock | Osteonic Co., Ltd. | 118 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 110 |
| Reunite Screw System | Biomet Orthopedics | 85 |
| ComposiTCP | S.B.M | 61 |
| ActivaScrew™ Interference | Bioretec Ltd. | 54 |
| Ligafix | S.B.M | 40 |
| Twinfix | Smith & Nephew, Inc. | 28 |
| Biosure | Smith & Nephew, Inc. | 27 |
| TorqLoc Interference | Bioretec Ltd. | 27 |
| FiberFIX | Nanova BIO Materials Inc | 25 |
| AlphaVent | Stryker GmbH | 23 |
Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193558 | 2020-03-18 |
| K151105 | 2015-07-28 |
| K143172 | 2015-02-04 |
| K142948 | 2015-01-13 |
| K123393 | 2013-04-11 |
| K101459 | 2011-01-27 |
| K093844 | 2010-04-01 |
| K032197 | 2003-08-08 |
| K011985 | 2001-11-02 |
| K011299 | 2001-06-27 |
Recalls Naming This Product
40 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
| Smith & Nephew, Inc. | 510(k) number | 2020-09-09 | Class II | Equipment maintenance | Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch | 263,874 (total) |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-04-08 | Class II | Process control | Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw | 2 units US and 193 units OUS. 195 units WW | 2022-06-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.