Smith & Nephew, Inc., Orthopaedic Div.
Memphis, TN, US
Smith & Nephew, Inc., Orthopaedic Div. appears in FDA device records in Memphis, TN. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Smith & Nephew, Inc., Orthopaedic Div. between 1996 and 1999. The busiest year on record is 1997, with 8. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 8 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K991538 | OPERA CUPFLANGED ACETABULAR COMPONENTS | JDI | Substantially Equivalent | |
| K970635 | TITANIUM SPINAL ROD SYSTEM | KWQ | Substantially Equivalent | |
| K971414 | ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS | LZO | Substantially Equivalent | |
| K970748 | TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | |
| K970751 | HEIDELBERG EXTERNAL FIXATOR | JDW | Substantially Equivalent | |
| K970713 | COMPASS UNIVERSAL HINGE | JDW | Substantially Equivalent | |
| K970351 | GLOBAL TAPER SPECTRON HIP STEMS | JDI | Substantially Equivalent | |
| K970337 | HA GLOBAL TAPER (GT) TAPERED HIP STEM | MEH | Substantially Equivalent | |
| K963255 | PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT | JWH | Substantially Equivalent for Some Indications | |
| K962784 | ULTIUM SPINAL PLATING SYSTEM | MNH | Substantially Equivalent for Some Indications |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWQAppliance, Fixation, Spinal Intervertebral Body
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- JDWPin, Fixation, Threaded
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Smith & Nephew, Inc., Orthopaedic Div. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Smith & Nephew, Inc., Orthopaedic Div.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain