Data / Medical devices / Mexico / Internacional Farmaceutica, S.A. De C.V.
Internacional Farmaceutica, S.A. De C.V.: FDA-registered device maker in LERMA Mexico, Mexico, 11 510(k) clearances
Internacional Farmaceutica, S.A. De C.V. is registered with the FDA (registration 3014273254) in LERMA Mexico, Mexico. It lists 8 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 3, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014273254
- Address
- Circuito De La Industria Poniente Lote 10-C Colonia Parque Industrial El Cerrillo, LERMA Mexico, Mexico, 52000
- Owner or operator
- INTERNACIONAL FARMACEUTICA, S.A. DE C.V. (9051246)
- Roles
- Manufacturer
- First device listed
- July 15, 2005
- Registered through
- 2026
- Brand names listed
- Atramat CHROMIC GUT, Atramat NYLON, Atramat PDX, Atramat PGA, Atramat PGA RAPID, Atramat PGC25, Atramat PGLA90, Atramat PGLA90 Calypso and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Suture, Absorbable, Natural | GAL | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Silk | GAP | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 3, 2025 | K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) | GAM | Substantially Equivalent | Internacional Farmacéutica S.A DE C.V | accessdata.fda.gov |
| May 23, 2008 | K072863 | ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES | GAM | Substantially Equivalent | Internacional Farmaceutica, S.A. DE C.V. | accessdata.fda.gov |
| May 23, 2008 | K072859 | ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES | GAM | Substantially Equivalent | Internacional Farmaceutica, S.A. DE C.V. | accessdata.fda.gov |
| June 4, 2004 | K041048 | POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE | NEW | Substantially Equivalent | Internacional Farmaceutica, S.A. DE C.V. | accessdata.fda.gov |
| April 29, 2004 | K040282 | ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID | GAM | Substantially Equivalent | Internacional Farmaceutica, S.A. DE C.V. | accessdata.fda.gov |
| December 4, 1991 | K913185 | STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT | GAQ | Substantially Equivalent | Internacional Farmaceutica, S.A. DE C.V. | accessdata.fda.gov |
| October 25, 1991 | K911354 | STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES | GAL | Substantially Equivalent | Internacional Farmaceutica, S.A. DE C.V. | accessdata.fda.gov |
| April 25, 1991 | K911189 | STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE | GAW | Substantially Equivalent | Internacional Farmaceutica, S.A. DE C.V. | accessdata.fda.gov |
| February 11, 1991 | K905287 | IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES | GAP | Substantially Equivalent | Internacional Farmaceutica, S.A. DE C.V. | accessdata.fda.gov |
| February 11, 1991 | K905286 | IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES | GAR | Substantially Equivalent | Internacional Farmaceutica, S.A. DE C.V. | accessdata.fda.gov |
| February 11, 1991 | K905285 | IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES | GAS | Substantially Equivalent | Internacional Farmaceutica, S.A. DE C.V. | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
- All makers of Suture, Nonabsorbable, Silk
- All makers of Suture, Nonabsorbable, Synthetic, Polyamide
- All makers of Suture, Nonabsorbable, Synthetic, Polypropylene
- All makers of Suture, Absorbable, Natural
- All makers of Suture, Surgical, Absorbable, Polydioxanone
Updated October 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.