SYNTHES LIGHT GUIDE
FDA 510(k) clearance K993314 · decided 1999-12-06
Clearance details
- K-number
- K993314
- Device name
- SYNTHES LIGHT GUIDE
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1999-10-04
- Decision date
- 1999-12-06
- Days to decision
- 63 days
- Clearance type
- Abbreviated
- Product code
- FQP
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ACULUX, MODEL AX3001, AX3002 (K001223) | Aculux | 2000-06-23 |
| SURGICAL LIGHT 22 SERIES (K781581) | American Sterilizer Co. | 1978-10-17 |
| HANDLES, LIGHT, SURGICAL, STEOILE (K770812) | Sybron Corp. | 1977-05-23 |
| SURGICAL LIGHT - CHALLENGE 22 SERIES (K761018) | Amsco Co. | 1977-01-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| NORIAN SRS CEMENT (P970010/S002) | Synthes (Usa) | 2000-04-28 |
| NORIAN SRS CEMENT (P970010/S001) | Synthes (Usa) | 1999-07-16 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |